GRIND GUARD

Mouthguard, Over-the-counter

ARCHTEK, INC.

The following data is part of a premarket notification filed by Archtek, Inc. with the FDA for Grind Guard.

Pre-market Notification Details

• Device ID: K073446
• 510k Number: K073446
• Device Name: GRIND GUARD
• Classification: Mouthguard, Over-the-counter
• Applicant: ARCHTEK, INC. 1705 SOUTH CAPITOL OF TEXAS HW Austin, TX 78746
• Contact: Ian P Gordon
• Correspondent: Ian P Gordon; ARCHTEK, INC. 1705 SOUTH CAPITOL OF TEXAS HW Austin, TX 78746
• 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: 2007-12-07
• Decision Date: 2008-02-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10311917190560	K073446	000