510(k) K213221
K213221 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoss GmbH for the device "AMADEO, M-UK1015 (incl. attachments and accessories)". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. W&H Dentalwerk Buermoss GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2022
- Date Received
- September 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device Class
- Class II
- Regulation Number
- 874.4250
- Review Panel
- EN
- Submission Type