Coltene/Whaledent, Inc.: FDA clearances and approvals
Coltene/Whaledent, Inc. has 22 FDA 510(k) clearances (first 1991, latest 2013), across 10 product codes in 2 review panels. Median 510(k) review time: 66 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 217 |
| 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 | 3 | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 | 3 |
| ELR | Post, Root Canal | 3 | 3 |
| EMA | Cement, Dental | 3 | 3 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| FRG | Wrap, Sterilization | 2 | 2 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KMH | Sterilizer, Dry Heat | 1 | 1 |
Review panels
- Dental (19)
- General Hospital (3)
Most recent Coltene/Whaledent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | ELC | 2013-08-23 | 217 |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | EKZ | 2007-10-18 | 126 |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | KMH | 2005-08-04 | 43 |
| K040551 | COLTOLUX LED CURING LIGHT | EBZ | 2004-03-15 | 13 |
| K033760 | ONE COAT SE BOND | KLE | 2004-01-23 | 52 |
| K031752 | COLTOSOL F | EMA | 2003-08-05 | 61 |
| K013400 | SYNERGY FLOW | EBF | 2001-12-10 | 56 |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | EBF | 2000-11-30 | 63 |
| K993545 | TENAX WHITE POST | ELR | 2000-04-14 | 178 |
| K000311 | PARAPOST FIBER WHITE | ELR | 2000-03-14 | 42 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coltene/Whaledent, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Coltene/Whaledent, Inc. have?
Coltene/Whaledent, Inc. has 22 FDA 510(k) clearances (first 1991, latest 2013), across 10 product codes in 2 review panels.
How long does FDA take to clear Coltene/Whaledent, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coltene/Whaledent, Inc.'s cleared 510(k)s is 66 days.
What devices does Coltene/Whaledent, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 3); EBZ (Activator, Ultraviolet, For Polymerization, 3); ELR (Post, Root Canal, 3).
Has Coltene/Whaledent, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coltene/Whaledent, Inc. Related entities may recall under other names.
Next steps
- See all 22 Coltene/Whaledent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Coltene/Whaledent, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.