Collagen Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Collagen Corp.” (first 1981, latest 1990), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 82 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 5 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EFS | Unit, Oral Irrigation | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 1 | 1 |
Review panels
Most recent Collagen Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904671 | QAR HANDPIECE | EFB | 1990-12-21 | 70 |
| K904228 | OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED) | DZE | 1990-11-09 | 87 |
| K901600 | OSSEOTITE IRRIGATION UNIT | EFS | 1990-06-21 | 76 |
| K900275 | OSSEODENT DENTAL ATTACHMENT, IGLOO MAGNET | DZE | 1990-04-19 | 90 |
| K895462 | OSSEODENT DENTAL ATTACHMENTS | DZE | 1990-04-04 | 210 |
| K895463 | OSSEODENT(R) PRECISION DENTAL ATTACHMENTS | DZE | 1990-03-28 | 203 |
| K894331 | OSSEODENT SURGICAL KIT | DZE | 1989-10-04 | 82 |
| K883322 | DENTAL HAND INSTRUMENTS | EKJ | 1988-08-26 | 21 |
| K812617 | VITROGEN TM 100 | KIT | 1981-10-02 | 17 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P860012 | PMA | ALVEOFORM TM BIOGRAFT | 1988-10-28 |
Recalls
openFDA lists no recalls under a recalling firm named Collagen Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Collagen Matrix, Inc. (47 510(k)s)
- Collagen Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Collagen Corp.?
FDA lists 9 510(k) clearances under the applicant name “Collagen Corp.” (first 1981, latest 1990), plus 1 PMA decision, across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Collagen Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Collagen Corp. is 82 days.
Which FDA product codes appear under Collagen Corp.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); EFB (Handpiece, Air-Powered, Dental, 1); EFS (Unit, Oral Irrigation, 1).
Next steps
- See all 9 Collagen Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Collagen Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.