Kerr Dental Materials Center: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Kerr Dental Materials Center” (first 1996, latest 2005), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 63 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Envista (Nobel Biocare, Ormco, Kerr), based on public ownership records.
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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 3 | 3 |
| EBD | Coating, Filling Material, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Dental (17)
Most recent Kerr Dental Materials Center 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050984 | BIOPLANT | LYC | 2005-08-11 | 114 |
| K031444 | OPTIBOND FL | KLE | 2003-07-02 | 56 |
| K030646 | BELLEGLASS POINT 4 | EBD | 2003-05-06 | 67 |
| K020303 | XR PRIMER 2 | KLE | 2002-04-19 | 80 |
| K020178 | BELLEGLASS HP MODELING GEL | EBG | 2002-03-15 | 56 |
| K020092 | TEMPHASE | EBG | 2002-02-22 | 43 |
| K014027 | OPTIBOND SOLO PLUS 4 | KLE | 2002-02-22 | 78 |
| K013375 | BELLEGLASS HP OPAQUE 2 | EBF | 2001-10-29 | 18 |
| K013325 | POINT 4 FLOWABLE 2 | EBF | 2001-10-23 | 18 |
| K011908 | OPTIBOND SOLO PLUS 3 | EBC | 2001-09-06 | 79 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kerr Dental Materials Center.
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.
- Kerr Corporation (41 510(k)s)
- Kerr Corporation (Danbury) (32 510(k)s)
- Kerr Hearing Aid Laboratory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kerr Dental Materials Center?
FDA lists 17 510(k) clearances under the applicant name “Kerr Dental Materials Center” (first 1996, latest 2005), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kerr Dental Materials Center?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kerr Dental Materials Center is 63 days.
Which FDA product codes appear under Kerr Dental Materials Center?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 5); KLE (Agent, Tooth Bonding, Resin, 4); EBG (Crown And Bridge, Temporary, Resin, 3).
Next steps
- See all 17 Kerr Dental Materials Center clearances with predicates and recalls
- Run predicate analysis for product code EBF, Kerr Dental Materials Center'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.