Coltene/Whaledent AG: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Coltene/Whaledent AG” (first 2005, latest 2019), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Since 2017 the median was 106 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 1 | 221 |
| 2014 | 0 | — |
| 2015 | 2 | 132 |
| 2016 | 2 | 222 |
| 2017 | 0 | — |
| 2018 | 1 | 69 |
| 2019 | 2 | 132 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Coltene/Whaledent AG took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 7 | 7 |
| EMA | Cement, Dental | 6 | 6 |
| ELW | Material, Impression | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (16)
Most recent Coltene/Whaledent AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191385 | BRILLIANT COMPONEER | EBF | 2019-10-29 | 159 |
| K190597 | BRILLIANT EverGlow Flow | EBF | 2019-06-21 | 106 |
| K181500 | BRILLIANT Crios | EBF | 2018-08-15 | 69 |
| K160800 | DuoCem | EMA | 2016-11-16 | 238 |
| K152927 | BRILLIANT EVERGLOW | EBF | 2016-04-28 | 206 |
| K152243 | One Coat 7 Universal | KLE | 2015-12-09 | 121 |
| K150218 | Fill-Up! | EBF | 2015-06-23 | 144 |
| K121621 | SOLOCEM | EMA | 2013-01-08 | 221 |
| K112168 | COMPONEER | EBF | 2011-11-21 | 116 |
| K083304 | TEMPOSIL 2 | EMA | 2009-02-06 | 88 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coltene/Whaledent AG.
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.
- Coltene/Whaledent, Inc. (22 510(k)s)
- Coltene/Whaledent GmbH & Co. KG (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coltene/Whaledent AG?
FDA lists 16 510(k) clearances under the applicant name “Coltene/Whaledent AG” (first 2005, latest 2019), across 4 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 Coltene/Whaledent AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coltene/Whaledent AG is 102 days. Since 2017: 106 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Coltene/Whaledent AG?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 7); EMA (Cement, Dental, 6); ELW (Material, Impression, 2).
Next steps
- See all 16 Coltene/Whaledent AG clearances with predicates and recalls
- Run predicate analysis for product code EBF, Coltene/Whaledent AG'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.