GRIND GUARD

Mouthguard, Prescription

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: 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