Buermoos, AT · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Class II | Dental | 1 | 2026-06-18 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, Nose, Throat | 1 | 2025-07-03 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Class I | Dental | 1 | 2021-02-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-01-16 | Class II | Ongoing | Z-1168-2024 | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 | — | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-18 | K253776 | Implantmed Plus II & Piezomed Plus II Module | DZI | Class II | Dental |
| 2025-07-03 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | ERL | Class II | Ear, Nose, Throat |
| 2021-02-24 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | EKX | Class I | Dental |