The following data is part of a premarket notification filed by Bite Tech Inc. with the FDA for Ora-guard Dental Grind Guard.
| Device ID | K150492 |
| 510k Number | K150492 |
| Device Name: | Ora-GUARD Dental Grind Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Bite Tech Inc. 20 Glover Avenue Norwalk, CT 06850 |
| Contact | Jeff Padovan |
| Correspondent | Alex Varond HYMAN, PHELPS & MCNAMARA, P.C. 700 13TH STREET NW, SUITE 1200 Washington, DC 20005 |
| 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 | 2015-02-25 |
| Decision Date | 2016-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816161015131 | K150492 | 000 |