What is the difference between a 510(k) clearance count and a GUDID device identifier count?

A 510(k) record is one premarket clearance decision. A GUDID device identifier (DI) is one labeled model or package in commercial distribution. One clearance can cover many DIs, so the two counts measure different things: Collagen Matrix holds 10 dental clearances and 206 active dental DIs, while Geistlich holds 20 clearances and 25 DIs.

Which FDA product codes cover dental bone grafting materials?

LYC (synthetic), NPM (animal source) and NUN (human source) are class II codes under 21 CFR 872.3930 and are cleared through 510(k). NPZ covers dental grafting material with a biologic component; it is class III and requires a PMA. Orthopedic bone void fillers use MQV and MBP under 21 CFR 888.3045.

Does FDA classification prevent putty or injectable carriers from being listed under dental codes?

The classification definitions for LYC and NPM describe intended use in the jaws and do not mention physical form. The registries show 32 active dental DIs described as putty and 8 as injectable, so such listings exist; they are simply rare compared with the 493 putty and 70 injectable DIs under the orthopedic code MQV, which uses the same class II 510(k) route.

How can the counts in this article be reproduced?

Each count is the meta.results.total value returned by an openFDA query listed in the Method section. Substituting a product code, a date range or a description term reproduces the other rows. openFDA refreshes its data regularly, so counts drift from the August 31 and September 2, 2026 snapshots used here.

Why Orthopedics Moved to Putty and Dentistry Did Not: A Reading of Two FDA Registries

Putty is 1.9% of active dental bone graft listings in GUDID and 11.9% of orthopedic MQV listings. What FDA's 510(k) and UDI registries show, with queries.

The FDA Global Unique Device Identification Database (GUDID) is the public registry in which a labeler records a device identifier (DI) for each model or package of a medical device it places into US commercial distribution. The FDA 510(k) database is a separate registry of premarket clearance decisions, one record per decision regardless of how many catalog items later ship under it. Read together for bone grafting materials, the two registries show a divide between specialties: under the orthopedic bone void filler code MQV, 493 of 4,150 active DIs describe a putty; under the three dental bone grafting codes, 32 of 1,679 do. This article sets out the counts, the codes behind them, the queries used and what a registry cannot show.

Key takeaways

Putty appears in 32 of 1,679 active dental bone graft DIs (1.9%) and in 493 of 4,150 active orthopedic MQV DIs (11.9%). Moldable: 3 against 211. Paste: 1 against 180. Gel: 0 against 109. Flowable: 0 against 15.
The dental 510(k) stream has contracted: 67 clearances across LYC, NPM and NUN in 2006–2010 against 19 in 2021–2026 (through August 31, 2026), 72% below the peak five-year window. The human-source code NUN has had no new clearance since January 10, 2014.
The route is not the obstacle. Seventy injectable and 211 moldable active DIs sit under MQV, a class II code cleared through the same 510(k) pathway as the dental codes, and eight companies hold positions in both clusters.
The dental catalog renews by adding SKUs rather than products: 202 new dental DIs were published in the 24 months to September 2, 2026, against 10 new dental clearances in the same window.
On November 11, 2025 Geistlich announced Geistlich Bio-Oss Flowable for 2026: 80% Bio-Oss and 20% Bio-Gide collagen, delivered through a flexible cannula.

Two registries, two questions

A clearance answers whether a device was found substantially equivalent to a predicate; a DI answers what is labeled and shipped now. The counts diverge by company: Collagen Matrix holds 10 clearances in the dental cluster and 206 active dental DIs under 58 brand names, while Geistlich holds 20 clearances after applicant-name normalization and 25 active DIs under 8 brand names. Registration and listing records show why catalogs spread: among establishments listed under LYC, 59 manufacture, 30 are recorded as “Develop Specifications But Do Not Manufacture” and 12 as “Contract Manufacturer”.

The product codes

Bone grafting materials for the jaws sit under 21 CFR 872.3930 in the Dental panel; bone void fillers for the skeleton sit under 21 CFR 888.3045 in the Orthopedic panel. Material, not form, sets the dental code: synthetic to LYC, animal-derived to NPM, human-derived to NUN; a growth-factor component moves a product to NPZ, class III, PMA, through which three original PMAs have passed in 27 years. The classification text does not mention physical form: LYC is defined as a device “intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw”, NPM identically for animal-source material, and the definition field is empty for MQV and MBP.

Code	FDA device name	Class	Regulation	Panel	510(k) clearances, all time	GUDID DIs, all	GUDID DIs in commercial distribution
LYC	Bone Grafting Material, Synthetic	II	21 CFR 872.3930	Dental	231	1,032	897
NPM	Bone Grafting Material, Animal Source	II	21 CFR 872.3930	Dental	40	801	762
NUN	Bone Grafting Material, Human Source	II	21 CFR 872.3930	Dental	15	163	151
MQV	Filler, Bone Void, Calcium Compound	II	21 CFR 888.3045	Orthopedic	492	4,678	4,150
MBP	Filler, Bone Void, Osteoinduction	II	21 CFR 888.3045	Orthopedic	31	815	not counted

The three dental codes together hold 286 clearances since 1979; MQV alone holds 492 since 1996. The dental union of 1,679 active DIs is smaller than 897 + 762 + 151 because a DI can carry two codes: 120 active DIs carry both LYC and NPM, and 11 carry LYC and NUN.

Forms in commercial distribution

The form comparison uses the free-text device_description field of active records; a record counts under every term its description contains, so rows are mentions rather than exclusive categories.

Term in device_description	Dental cluster, active DIs (n = 1,679)	Orthopedic MQV, active DIs (n = 4,150)
putty	32 (1.9%)	493 (11.9%)
moldable / mouldable	3	211
paste	1	180
strip / strips	4	241
foam	2	147
gel	0	109
injectable	8	70
flowable	0	15
powder	0	103
syringe	74	145
granule / granular	160	596
particulate / particle	174	303
cortical / cancellous	182	49
block	43	193
membrane / membranes	126	0
plug	50	0

Loose material dominates the dental catalog: particulate, granule and cortical/cancellous terms account for 516 mentions across 1,679 records, and the 182 cortical/cancellous mentions fall under NPM (169) and NUN (13), none under LYC. Seventy-four dental DIs mention a syringe; with putty at 32 and injectable at 8, most are read here as granule dispensers, an interpretation rather than a registry field. On the orthopedic side, putty, strip, moldable, paste, foam and gel together account for 1,381 mentions across 4,150 records. The 510(k) device names repeat the pattern: “putty” appears in 12 dental and 75 MQV device names, “injectable” in 0 and 8.

The clearance stream

By five-year decision window, dental clearances across LYC, NPM and NUN ran 40 (1996–2000), 45, 67 (2006–2010), 33, 16 and 19 (2021 through August 31, 2026); MQV ran 13, 114, 130, 75, 76 and 84. The dental stream is 72% below its peak, while MQV has stayed between 75 and 84 per window since 2011. Within dentistry the material mix turned over: LYC fell from 55 clearances in 2006–2010 to 8 in 2021–2026 while NPM rose from 3 to 11. NUN received 15 clearances between April 29, 2005 and January 10, 2014 and none since; the last, K130235 from Hans Biomed, is named “SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY”, and 151 NUN DIs remain active on those older clearances.

In the 24 months from September 10, 2024 the dental codes added 10 clearances (LYC 6, NPM 4, NUN 0), five of the six LYC clearances going to applicants outside the United States. MQV added 30, among them Biocomposites NanoBone SBX Putty, Novabone Putty, SeaSpine Cove Putty and Geistlich “Putty”. On August 21, 2025 FDA finalized the guidance “Animal Studies for Dental Bone Grafting Material Devices — Premarket Notification (510(k)) Submissions” (docket FDA-2024-D-1242), which concerns preclinical animal evidence.

The route is open; the listings are not there

Nothing in the registries points to a barrier specific to plastic or injectable carriers. MQV and the three dental codes are class II and are cleared through the same 510(k) route, and 70 injectable and 211 moldable DIs are active under MQV. Geistlich, Collagen Matrix, Novabone, Biomatlante, Curasan, Medtronic, Hans Biomed and Etex each hold positions in both clusters. What differs is what has been listed for the jaw and how the dental catalog grows: between September 10, 2024 and September 2, 2026 it gained 202 DIs against 10 clearances, with Collagen Matrix accounting for 89 of the 202 and Geistlich for 6. MQV gained 461 DIs in the same window.

Against that background, on November 11, 2025 Geistlich announced Geistlich Bio-Oss Flowable for 2026, described as “80% Geistlich Bio-Oss and 20% Geistlich Bio-Gide collagen” delivered through a flexible cannula. The registries already hold related entries: a 510(k) for Geistlich “Bio-Flow” (K242510) was cleared under NPM on March 7, 2025, and GUDID lists two active DIs under the brand name “Geistlich Bio-Oss Flow”. The sources consulted do not state whether these records correspond to the announced product.

Method

Data came from three openFDA endpoints: device/classification.json for product codes, regulation numbers, panels and definitions; device/510k.json for clearances (fields product_code, decision_date, applicant, device_name); and device/udi.json, the openFDA mirror of GUDID (fields product_codes.code, commercial_distribution_status, device_description, publish_date, company_name, brand_name). The 510(k) and classification data carry a last-updated date of August 31, 2026; the UDI data, September 2, 2026. Counts were taken from the openFDA mirror of GUDID rather than from the AccessGUDID web interface.

“Active” means commercial_distribution_status equal to “In Commercial Distribution”, matched with the .exact suffix; without it the tokenized field also matches “Not in Commercial Distribution”. The dental cluster is the union of LYC, NPM and NUN; NPZ, the membrane codes NPL and NPK and the wound dressing code KGN were excluded. Form terms were matched as tokens in device_description, with variants merged where they exist (strip + strips = 241; moldable + mouldable = 211; membrane + membranes = 126). New DIs are records whose publish_date falls between September 10, 2024 and September 2, 2026, regardless of current status. Company counts used company_name in GUDID and applicant in 510(k), with applicant spellings normalized by hand. Each count is the meta.results.total value of the response.

Representative queries, reproducible in a browser:

Active dental DIs mentioning putty (32): https://api.fda.gov/device/udi.json?search=(product_codes.code:LYC+OR+product_codes.code:NPM+OR+product_codes.code:NUN)+AND+commercial_distribution_status.exact:%22In+Commercial+Distribution%22+AND+device_description:putty&limit=1
Active MQV DIs mentioning putty (493): https://api.fda.gov/device/udi.json?search=product_codes.code:MQV+AND+commercial_distribution_status.exact:%22In+Commercial+Distribution%22+AND+device_description:putty&limit=1
Dental clearances 2006–2010 (67): https://api.fda.gov/device/510k.json?search=(product_code:LYC+OR+product_code:NPM+OR+product_code:NUN)+AND+decision_date:[2006-01-01+TO+2010-12-31]&limit=1
Most recent NUN clearance (K130235): https://api.fda.gov/device/510k.json?search=product_code:NUN&sort=decision_date:desc&limit=1
New dental DIs in 24 months (202): https://api.fda.gov/device/udi.json?search=(product_codes.code:LYC+OR+product_codes.code:NPM+OR+product_codes.code:NUN)+AND+publish_date:[2024-09-10+TO+2026-09-02]&limit=1
Classification record for a code: https://api.fda.gov/device/classification.json?search=product_code:LYC

The headline counts were re-run on September 11, 2026 and matched the snapshot figures.

What this does and does not show

A registry measures listings, not use. A DI is one labeled model or package, so a DI count says how many packages are labeled for sale, not how many are opened in operatories; a clearance count says how many decisions were issued, not how many products remain in use. Neither registry records units, revenue or clinician preference.

The form terms depend on labelers’ free text. A description reading “bone graft substitute, 0.5 cc” contributes to no form row even if the product is a putty, and a granule product described as having a “putty-like consistency” counts as putty. Rows are mentions, so they do not sum to the base, and inflections beyond those listed were not searched.

Product codes do not map onto specialties exactly. The NUN classification text refers to dental, oral and cranio-/maxillofacial defects, some craniomaxillofacial products sit under codes not examined here, and a product used in the jaw under an MQV clearance leaves no dental trace in either registry.

Snapshots drift: openFDA refreshes its data regularly, records move in and out of commercial distribution, and the 2021–2026 window is incomplete. openFDA’s terms describe its data as unvalidated, and company-level figures rest on name matching, which undercounts firms that list through subsidiaries or distributors.

Why we wrote this

This article is written for implant surgeons, periodontists and oral surgeons in the United States who choose grafting materials and want the regulatory record behind the catalog, with counts they can re-run rather than a market estimate taken on faith. It is not patient guidance and does not recommend any product.

Disclosure: this site is operated by Meddent Innovative Concepts, the developer of ALGINAGRAFT™, a dental bone grafting technology in development that has not been cleared or approved by FDA and is not for sale. The author is the founder of that company and has a financial interest in the question of dental graft form. The counts come from public FDA registries and can be verified with the queries listed; the interpretation is the author’s.