Kerr Corporation (Danbury): FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Kerr Corporation (Danbury)” (first 1978, latest 2005), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 7 | 7 |
| EMA | Cement, Dental | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EJJ | Alloy, Amalgam | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (31)
- Ear, Nose and Throat (1)
Most recent Kerr Corporation (Danbury) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051545 | L.E. DEMETRON II | EBZ | 2005-07-18 | 38 |
| K020091 | OPTILUX 501 | EBZ | 2002-03-21 | 70 |
| K951663 | TYTIN R | EJJ | 1995-06-06 | 57 |
| K951511 | TYTIN ADMIX | EJJ | 1995-05-02 | 29 |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | EGS | 1995-01-27 | 247 |
| K940513 | OPTIBOND | KLE | 1994-04-15 | 70 |
| K935535 | TYTIN | EJJ | 1994-03-11 | 115 |
| K934690 | KERR OPTIBOND, MODIFICATION | KLE | 1993-12-30 | 157 |
| K923546 | OPTIBOND | KLE | 1992-09-29 | 75 |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | EFD | 1992-03-02 | 67 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kerr Corporation (Danbury).
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 Dental Materials Center (17 510(k)s)
- Kerr Hearing Aid Laboratory (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kerr Corporation (Danbury)?
FDA lists 32 510(k) clearances under the applicant name “Kerr Corporation (Danbury)” (first 1978, latest 2005), across 14 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 Kerr Corporation (Danbury)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kerr Corporation (Danbury) is 70 days.
Which FDA product codes appear under Kerr Corporation (Danbury)?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 7); EMA (Cement, Dental, 4); EBF (Material, Tooth Shade, Resin, 3).
Next steps
- See all 32 Kerr Corporation (Danbury) clearances with predicates and recalls
- Run predicate analysis for product code KLE, Kerr Corporation (Danbury)'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.