The following data is part of a premarket notification filed by Akervall Technologies Inc with the FDA for Protech Dent.
| Device ID | K121272 |
| 510k Number | K121272 |
| Device Name: | PROTECH DENT |
| Classification | Mouthguard, Over-the-counter |
| Applicant | AKERVALL TECHNOLOGIES INC 5520 STONE VALLEY DRIVE Ann Arbor, MI 48105 |
| Contact | Sassa Akervall |
| Correspondent | Sassa Akervall AKERVALL TECHNOLOGIES INC 5520 STONE VALLEY DRIVE Ann Arbor, MI 48105 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-27 |
| Decision Date | 2012-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858286007646 | K121272 | 000 |