W&H Dentalwerk Buermoos GmbH: FDA clearances and approvals
W&H Dentalwerk Buermoos GmbH has 18 FDA 510(k) clearances (first 1999, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time: 190 days. Since 2017 its median was 247 days, against 246 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named W&H Dentalwerk Buermoos GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 337 |
| 2015 | 1 | 329 |
| 2016 | 0 | — |
| 2017 | 1 | 192 |
| 2018 | 0 | — |
| 2019 | 1 | 257 |
| 2020 | 0 | — |
| 2021 | 1 | 247 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 259 |
| 2026 | 1 | 204 |
Review time against the same product codes
Since 2017, W&H Dentalwerk Buermoos GmbH's cleared 510(k)s took a median 247 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 246 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | 5 | 5 |
| EFB | Handpiece, Air-Powered, Dental | 3 | 3 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 3 | 3 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| DZA | Drill, Dental, Intraoral | 1 | 1 |
| EGM | Injector, Jet, Mechanical-Powered | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| KMW | Handpiece, Rotary Bone Cutting | 1 | 1 |
Review panels
- Dental (17)
- Ear, Nose and Throat (1)
Most recent W&H Dentalwerk Buermoos GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II Module | DZI | 2026-06-18 | 204 |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | ERL | 2025-07-03 | 259 |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | EKX | 2021-02-24 | 247 |
| K181858 | Electric Handpiece Motor | EBW | 2019-03-26 | 257 |
| K171553 | W&H Assistina Twin | EFB | 2017-12-08 | 192 |
| K143704 | Advanced Air System | EFB | 2015-11-23 | 329 |
| K133488 | PIEZOMED | DZI | 2014-10-16 | 337 |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | EKX | 2010-07-09 | 128 |
| K083811 | W&H HANDPIECE ANESTO, MODEL: RA-5 | EGM | 2010-01-14 | 388 |
| K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | EKX | 2009-12-15 | 257 |
8 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2024-01-16.
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 W&H Dentalwerk Buermoos GmbH have?
W&H Dentalwerk Buermoos GmbH has 18 FDA 510(k) clearances (first 1999, latest 2026), across 9 product codes in 2 review panels.
How long does FDA take to clear W&H Dentalwerk Buermoos GmbH's 510(k)s?
The median time from FDA receipt to decision across W&H Dentalwerk Buermoos GmbH's cleared 510(k)s is 190 days. Since 2017: 247 days, versus 246 days for all cleared 510(k)s in the same product codes.
What devices does W&H Dentalwerk Buermoos GmbH make?
Its most frequent FDA product codes are EBW (Controller, Foot, Handpiece And Cord, 5); EFB (Handpiece, Air-Powered, Dental, 3); EKX (Handpiece, Direct Drive, Ac-Powered, 3).
Has W&H Dentalwerk Buermoos GmbH had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches W&H Dentalwerk Buermoos GmbH; the most recent began 2024-01-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 W&H Dentalwerk Buermoos GmbH clearances with predicates and recalls
- Run predicate analysis for product code EBW, W&H Dentalwerk Buermoos GmbH'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.