K213221 is an FDA 510(k) clearance for the AMADEO, M-UK1015 (incl. attachments and accessories). This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by W&H Dentalwerk Buermoss GmbH (Buermoos, AT). The FDA issued a Cleared decision on May 26, 2022, 239 days after receiving the submission on September 29, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K213221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | May 26, 2022 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ERL - Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4250 |