The following data is part of a premarket notification filed by W&h Dentalwerk Buermoss Gmbh with the FDA for Amadeo, M-uk1015 (incl. Attachments And Accessories).
| Device ID | K213221 |
| 510k Number | K213221 |
| Device Name: | AMADEO, M-UK1015 (incl. Attachments And Accessories) |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53 Buermoos, AT 5111 |
| Contact | Weidler Gerhard |
| Correspondent | Weidler Gerhard W&H Dentalwerk Buermoss GmbH Ignaz-Glaser-Strasse 53 Buermoos, AT 5111 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-05-26 |