The following data is part of a premarket notification filed by Archtek, Inc. with the FDA for Grind Guard.
| Device ID | K090472 |
| 510k Number | K090472 |
| Device Name: | GRIND GUARD |
| Classification | Mouthguard, Prescription |
| Applicant | ARCHTEK, INC. 1705 SOUTH CAPITOL OF TEXAS HW Austin, TX 78746 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes ARCHTEK, INC. 1705 SOUTH CAPITOL OF TEXAS HW Austin, TX 78746 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-24 |
| Decision Date | 2009-10-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GRIND GUARD 86217963 4655574 Live/Registered |
ARCHTEK DENTAL, LLC 2014-03-11 |
![]() GRIND GUARD 78009323 not registered Dead/Abandoned |
WILSON, RON P 2000-05-22 |
![]() GRIND GUARD 76710846 not registered Dead/Abandoned |
Archtek, Inc. 2012-03-08 |