Sirona Dental Systems GmbH: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Sirona Dental Systems GmbH” (first 1998, latest 2016), across 15 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 | 1 | 273 |
| 2013 | 5 | 97 |
| 2014 | 1 | 388 |
| 2015 | 4 | 100 |
| 2016 | 1 | 135 |
| 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | 7 | 7 |
| EIH | Powder, Porcelain | 6 | 6 |
| EIA | Unit, Operative Dental | 4 | 4 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 | 3 |
| ELC | Scaler, Ultrasonic | 3 | 3 |
| ELW | Material, Impression | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
Plus 5 more product codes.
Review panels
- Dental (25)
- Radiology (14)
- General and Plastic Surgery (3)
Most recent Sirona Dental Systems GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160099 | CEREC SpeedGlaze | EIH | 2016-06-02 | 135 |
| K151045 | TENEO Dental Treatment Unit and Accessories | EIA | 2015-07-24 | 95 |
| K150909 | INTEGO Family and Accesories | EIA | 2015-07-17 | 105 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | EGS | 2015-07-02 | 101 |
| K150217 | ORTHOPHOS SL | OAS | 2015-05-08 | 98 |
| K131319 | T1/T2/T3 TURBINE FAMILY | EFB | 2014-05-30 | 388 |
| K132773 | SIDEXIS 4 | LLZ | 2013-12-11 | 97 |
| K123664 | INCORIS ZI | EIH | 2013-04-08 | 131 |
| K123952 | CEREC BLOCS C IN | EIH | 2013-03-20 | 89 |
| K123070 | GALILEOS FAMILY | OAS | 2013-03-15 | 165 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sirona Dental Systems GmbH.
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.
- Sirona Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sirona Dental Systems GmbH?
FDA lists 42 510(k) clearances under the applicant name “Sirona Dental Systems GmbH” (first 1998, latest 2016), across 15 product codes in 3 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 Sirona Dental Systems GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sirona Dental Systems GmbH is 76 days.
Which FDA product codes appear under Sirona Dental Systems GmbH?
The most frequent FDA product codes under this applicant name are MUH (System, X-Ray, Extraoral Source, Digital, 7); EIH (Powder, Porcelain, 6); EIA (Unit, Operative Dental, 4).
Next steps
- See all 42 Sirona Dental Systems GmbH clearances with predicates and recalls
- Run predicate analysis for product code MUH, Sirona Dental Systems GmbH'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.