Implantmed Plus II & Piezomed Plus II Module— 510(k) K253776
Substantially EquivalentW&H Dentalwerk Buermoos GmbH
FDA 510(k) clearance K253776 for Implantmed Plus II & Piezomed Plus II Module, Substantially Equivalent on 2026-06-18. Applicant: W&H Dentalwerk Buermoos GmbH. Device class: 2.
Summary
W&H Dentalwerk Buermoos' clearance names the Implantmed Plus II and the Piezomed Plus II Module, filed under DZI, powered bone drills. The record doesn't describe either one beyond the names and the code name.
Class II, 21 CFR 872.4120. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
W&H filed from Buermoos, Austria. Review took 204 calendar days (November 26, 2025 to June 18, 2026).
Clearance details
- Applicant
- W&H Dentalwerk Buermoos GmbH
- Product code
- Product code DZI
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buermoos, AT
Recent devices under product code DZI
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