Dentsply Interntional: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Dentsply Interntional” (first 2007, latest 2009), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 Dentsply Sirona, 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 2 | 2 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| NJM | Bracket, Ceramic, Orthodontic | 2 | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (13)
Most recent Dentsply Interntional 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092614 | X-SMART EASY | EKX | 2009-12-02 | 98 |
| K092030 | ELATION MB METAL REINFORCED PLASTIC BRACKET | DYW | 2009-07-24 | 18 |
| K090454 | ALLURE MB CERAMIC BRACKETS | NJM | 2009-03-20 | 25 |
| K082973 | STER-MATE STERILE LAVAGE KIT | ELC | 2009-01-29 | 115 |
| K082974 | MYSTIQUE MB CERAMIC BRACKETS | NJM | 2008-11-07 | 32 |
| K081291 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION | DYH | 2008-05-22 | 15 |
| K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM | EBG | 2008-04-18 | 72 |
| K080246 | COMPOSITE ALIGNER BUTTON | NXC | 2008-04-11 | 71 |
| K080203 | MTA ROOT CANAL SEALER | KIF | 2008-03-26 | 58 |
| K073173 | SELF-ADHESIVE RESIN CEMENT | EMA | 2008-01-23 | 71 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentsply Interntional.
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.
- Dentsply Intl. (291 510(k)s)
- Dentsply Sirona (88 510(k)s)
- Dentsply International, Inc. (59 510(k)s)
- Dentsply Ceramco (1 510(k)s)
- Dentsply Gendex (1 510(k)s)
- Dentsply Implant (1 510(k)s)
- Dentsply Implants Manufacturing GmbH (1 510(k)s)
- Dentsply Midwest (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dentsply Interntional?
FDA lists 13 510(k) clearances under the applicant name “Dentsply Interntional” (first 2007, latest 2009), across 10 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 Dentsply Interntional?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentsply Interntional is 58 days.
Which FDA product codes appear under Dentsply Interntional?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 2); LYC (Bone Grafting Material, Synthetic, 2); NJM (Bracket, Ceramic, Orthodontic, 2).
Next steps
- See all 13 Dentsply Interntional clearances with predicates and recalls
- Run predicate analysis for product code KIF, Dentsply Interntional'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.