The following data is part of a premarket notification filed by Kavo Dental Gmbh with the FDA for Surgmatic S15 L Pro.
| Device ID | K213139 |
| 510k Number | K213139 |
| Device Name: | SURGmatic S15 L Pro |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | KaVo Dental GmbH Bismarckring 39 Biberach, DE 88400 |
| Contact | Kerstin Henseler |
| Correspondent | Kerstin Henseler KaVo Dental GmbH Bismarckring 39 Biberach, DE 88400 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-27 |
| Decision Date | 2021-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101440000 | K213139 | 000 |