Dentsply Intl.: FDA clearances and approvals
Dentsply Intl. has 291 FDA 510(k) clearances (first 1976, latest 2014), across 70 product codes in 7 review panels. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 104 |
| 2014 | 1 | 190 |
| 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 | 28 | 28 |
| EIH | Powder, Porcelain | 23 | 23 |
| KLE | Agent, Tooth Bonding, Resin | 20 | 20 |
| EMA | Cement, Dental | 19 | 19 |
| ELW | Material, Impression | 18 | 18 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 16 | 16 |
| ELC | Scaler, Ultrasonic | 13 | 13 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 11 | 11 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 8 | 8 |
| EFB | Handpiece, Air-Powered, Dental | 8 | 8 |
Plus 60 more product codes.
Review panels
- Dental (266)
- Radiology (7)
- Orthopedic (4)
- Anesthesiology (3)
- Ophthalmic (3)
- General Hospital (2)
- Neurology (2)
Most recent Dentsply Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140347 | ANKYLOS C/X IMPLANT SYSTEM | DZE | 2014-08-20 | 190 |
| K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | ELC | 2013-07-23 | 117 |
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | EIH | 2013-02-22 | 91 |
| K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | KJJ | 2011-02-14 | 104 |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | DYH | 2009-10-30 | 17 |
| K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | DZE | 2009-05-22 | 151 |
| K082198 | DURASHIELD PLUS | LBH | 2008-10-29 | 86 |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | NHA | 2008-03-27 | 183 |
| K072989 | AXIS SYSTEM | EFB | 2008-01-28 | 97 |
| K073117 | DENTIN DESENSITIZER AGENT | LBH | 2007-12-19 | 44 |
281 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentsply Intl..
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 Dentsply Intl. have?
Dentsply Intl. has 291 FDA 510(k) clearances (first 1976, latest 2014), across 70 product codes in 7 review panels.
How long does FDA take to clear Dentsply Intl.'s 510(k)s?
The median time from FDA receipt to decision across Dentsply Intl.'s cleared 510(k)s is 55 days.
What devices does Dentsply Intl. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 28); EIH (Powder, Porcelain, 23); KLE (Agent, Tooth Bonding, Resin, 20).
Has Dentsply Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dentsply Intl. Related entities may recall under other names.
Next steps
- See all 291 Dentsply Intl. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Dentsply Intl.'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.