Manufacturer registered with FDA
Collagen Matrix, Inc.
Oakland, NJ, United States. Lists 5 dental device types with FDA across 3 registered establishments, and holds 20 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 20
- 510(k) clearances
- 202001–2024
- Markets registered in
- 16585 registrations outside the US
- Establishments
- 3United States
510(k) clearances per year, 2000–2026
Registered in 16 markets
Where regulators' registries name Collagen Matrix, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Collagen Matrix, Inc. | 20 clearances | 2001–2024 | Below |
| European Union | EUDAMED | Manufacturer | Collagen Matrix Inc | 244 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | COLLAGEN MATRIX, INC. | 122 | 2002–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | COLLAGEN MATRIX INCCOLLAGEN MATRIX INC. · COLLAGEN MATRIX, INC · +2 | 45 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Collagen Matrix Inc | 34 | 2008–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | COLLAGEN MATRIX INC.COLLAGEN MATRIX , INC · COLLAGEN MATRIX, INC. · +2 | 30 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Collagen Matrix, Inc.Collagen Matrix Inc. · Collagen Matrix, Inc | 26 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | COLLAGEN MATRIX, INC.Collagen Matrix Inc. · Collagen Matrix, Inc. | 22 | 2008–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Collagen Matrix, Inc.Collagen Matrix Inc. · Collagen Matrix Inc | 21 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | COLLAGEN MATRIX, INCCOLLAGEN MATRIX, INC. · COLLAGEN MATRIX INC | 11 | 2021–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | COLLAGEN MATRIX INCCOLLAGEN MATRIX, INC. | 7 | 2011–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Collagen Matrix, Inc.collagen matrix, Inc. | 7 | 2003–2019 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Collagen Matrix, Inc. | 6 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Collagen Matrix, Inc. | 5 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Collagen Matrix, Inc. | 3 | 2007–2026 | Pure Global AI |
| China | NMPA | Registration holder | 科欧格有限公司Collagen Matrix, Inc. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Collagen Matrix, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | MatrixDerm CAP Regenerative Collagen Dental MembraneMatrixDerm EXT Regenerative Collagen Dental MembraneMatrixDerm Regenerative Collagen Dental MembraneMatrixflexMatrixMem Regenerative Collagen Dental MembraneX-FLEX | 2006 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | MatrixOss GranulesMatrixOss SyringeSynOss PlugX-GEN GranulesX-GEN Syringe | 2005 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Guidor easy-graft CLASSICGuidor easy-graft CLASSIC+Guidor easy-graft CRYSTALGuidor easy-graft CRYSTAL+SynOss GranulesSynOss PlugSynOss Synthetic Bone Graft Material | 2007 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | GUIDOR ES MembraneGUIDOR Resorbable Matrix Barrier | 2021 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Collagen Matrix, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 May 2024 | K233203 | Soft Tissue Augmentation Resorbable Matrix | NPL Intraoral Animal Source Barrier |
| 2 Apr 2021 | K202183 | Porcine Mineral Collagen Composite | NPM Animal Source Bone Grafting Material |
| 11 Sep 2020 | K201859 | Porcine Mineral Collagen Composite Moldable | NPM Animal Source Bone Grafting Material |
| 30 Oct 2017 | K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | NPM Animal Source Bone Grafting Material |
| 7 Jul 2017 | K170541 | Anorganic Bone Mineral in Delivery Applicator | NPM Animal Source Bone Grafting Material |
| 9 Feb 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | NPM Animal Source Bone Grafting Material |
| 24 Nov 2014 | K142496 | Collagen Dental Membrane - Conformable IIBP | NPL Intraoral Animal Source Barrier |
| 5 Nov 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | NPL Intraoral Animal Source Barrier |
| 16 Jul 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | NPM Animal Source Bone Grafting Material |
| 29 Jul 2011 | K110600 | COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN | NPL Intraoral Animal Source Barrier |
| 11 Aug 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | NPL Intraoral Animal Source Barrier |
| 18 Sep 2009 | K090216 | COLLAGEN DENTAL MEMBRANE IV | NPL Intraoral Animal Source Barrier |
| 12 Feb 2009 | K083742 | SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX | LYC Synthetic Bone Grafting Material |
| 18 Oct 2007 | K072397 | SYNOSS SYNTHETIC BONE GRAFT MATERIAL | LYC Synthetic Bone Grafting Material |
| 13 Oct 2006 | K062846 | COLLAGEN DENTAL MEMBRANE III | NPL Intraoral Animal Source Barrier |
| 11 Oct 2006 | K062881 | COLLAGEN DENTAL MENBRANE - CONFORMABLE II | NPL Intraoral Animal Source Barrier |
| 4 Aug 2005 | K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | NPM Animal Source Bone Grafting Material |
| 17 Mar 2004 | K033729 | COLLAGEN DENTAL WOUND DRESSINGS | LYC Synthetic Bone Grafting Material |
| 7 Aug 2001 | K011695 | COLLAGEN DENTAL MEMBRANE | NPL Intraoral Animal Source Barrier |
| 8 Jan 2001 | K003339 | COLLAGEN PERIODONTAL MEMBRANE | NPL Intraoral Animal Source Barrier |
Some of these clearances are listed with FDA today by another company: Osteogenics Biomedical, Inc. (5), Young Innovations Inc (4), Neoss AB (4), Park Dental Research Corp (4), Dentsply Sirona, Inc. (3), Prismatik Dentalcraft, Inc. (3).
Also lists devices cleared under other names
Collagen Matrix, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Osteogenics Biomedical, Inc. (Formerly Obi Biologi (1), Sunstar Americas, Inc. (1), Degradable Solutions AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Sep 2015 | K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | NPL Intraoral Animal Source Barrier |
| 29 Oct 2013 | K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | NPK Intraoral Synthetic Barrier |
| 27 Sep 2013 | K131385 | EASY-GRAFT | Degradable Solutions AG | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Collagen Matrix, IncFDA reg. 3003300673 | Allendale, NJ, United States | Manufacturer for export, Manufacturer, Specification developer |
| Collagen Matrix, Inc.FDA reg. 3027448274 | Mahwah, NJ, United States | Repacker / relabeler |
| COLLAGEN MATRIX, INC.FDA reg. 2249852 | Oakland, NJ, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9043463). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.