Kaltenbach & Voigt GmbH: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Kaltenbach & Voigt GmbH” (first 2008, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 190 days. Since 2017 the median was 348 days, against 265 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 | 2 | 265 |
| 2014 | 1 | 189 |
| 2015 | 1 | 126 |
| 2016 | 1 | 190 |
| 2017 | 1 | 119 |
| 2018 | 0 | — |
| 2019 | 2 | 385 |
| 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 Kaltenbach & Voigt GmbH took a median 348 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 265 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 3 | 3 |
| EBW | Controller, Foot, Handpiece And Cord | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 2 | 2 |
| EIA | Unit, Operative Dental | 2 | 2 |
| NTK | Light Transmission Caries Detector | 2 | 2 |
Review panels
- Dental (11)
Most recent Kaltenbach & Voigt GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182712 | DEXIS CariVu 3-in-1 by KaVo | NTK | 2019-11-23 | 422 |
| K181110 | PROPHYflex 4 | EFB | 2019-04-10 | 348 |
| K163239 | SMARTmatic | EFA | 2017-03-17 | 119 |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | EIA | 2016-12-08 | 190 |
| K143465 | MASTERmatic LUX | EFA | 2015-04-09 | 126 |
| K140308 | MASTERSURG / EXPERTSURG | EBW | 2014-08-15 | 189 |
| K130560 | MASTERTORQUE LUX 8900 L | EFB | 2013-09-27 | 207 |
| K123402 | DIAGNOCAM | NTK | 2013-09-24 | 323 |
| K103027 | ELECTROTORQUE TLC | EBW | 2011-08-19 | 310 |
| K092446 | INTRA LUX HEAD 3 LDSY | EFA | 2009-11-03 | 85 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kaltenbach & Voigt 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.
- Kaltenbach & Voigt Gmgh (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kaltenbach & Voigt GmbH?
FDA lists 11 510(k) clearances under the applicant name “Kaltenbach & Voigt GmbH” (first 2008, latest 2019), across 5 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 Kaltenbach & Voigt GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kaltenbach & Voigt GmbH is 190 days. Since 2017: 348 days, versus 265 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kaltenbach & Voigt GmbH?
The most frequent FDA product codes under this applicant name are EFA (Handpiece, Belt And/Or Gear Driven, Dental, 3); EBW (Controller, Foot, Handpiece And Cord, 2); EFB (Handpiece, Air-Powered, Dental, 2).
Next steps
- See all 11 Kaltenbach & Voigt GmbH clearances with predicates and recalls
- Run predicate analysis for product code EFA, Kaltenbach & Voigt 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, 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.