Ceramed Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Ceramed Corp.” (first 1989, latest 1996), plus 1 PMA decision, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 13 | 13 |
| LZK | Implant, Malar | 2 | 2 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
| NPZ | Bone Grafting Material, Dental, With Biologic Component | 1 | 0 |
Review panels
- Dental (14)
- General and Plastic Surgery (3)
Most recent Ceramed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962838 | PERMARIDGE SYRINGE | LYC | 1996-08-20 | 29 |
| K962786 | OSTEOGRAF STAINLESS STEEL SYRING | LYC | 1996-08-01 | 15 |
| K960348 | OSTEOGRAF/N-300 HYDROXYLAPATITE | LYC | 1996-04-22 | 88 |
| K960368 | OSTEOGRAFT/N-700 HYDROXYLAPTITE | LYC | 1996-04-18 | 84 |
| K960353 | OSTEOGRAF/LD-300 HYDROXYLAPATITE | LYC | 1996-04-18 | 84 |
| K960361 | PERMAMESH-D HYDROXYLAPATITE MATRIX | LYC | 1996-04-15 | 81 |
| K960362 | PERMAMESH HYDROXYLAPATITE MATRIX | LZK | 1996-03-20 | 55 |
| K960354 | PERMAMESH-D HYDROXYLAPATITE MATRIX | LZK | 1996-03-20 | 55 |
| K960349 | PERMARIDGE HYDROXYLAPATITE MATRIX | FWP | 1996-03-13 | 48 |
| K954631 | OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE | LYC | 1996-01-02 | 88 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990033 | PMA | PEPGEN P-15 | 1999-10-25 |
Recalls
openFDA lists no recalls under a recalling firm named Ceramed 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.
- Ceramed Dental, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ceramed Corp.?
FDA lists 16 510(k) clearances under the applicant name “Ceramed Corp.” (first 1989, latest 1996), plus 1 PMA decision, across 4 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 Ceramed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ceramed Corp. is 86 days.
Which FDA product codes appear under Ceramed Corp.?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 13); LZK (Implant, Malar, 2); FWP (Prosthesis, Chin, Internal, 1).
Next steps
- See all 16 Ceramed Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Ceramed 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.