GRINDGUARD

Mouthguard, Over-the-counter

GRIND GUARD TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Grind Guard Technologies, Llc with the FDA for Grindguard.

Pre-market Notification Details

• Device ID: K133037
• 510k Number: K133037
• Device Name: GRINDGUARD
• Classification: Mouthguard, Over-the-counter
• Applicant: GRIND GUARD TECHNOLOGIES, LLC 342 E. MAIN STREET SUITE 207 Leola, PA 17540
• Contact: William G Mclain
• Correspondent: William G Mclain; GRIND GUARD TECHNOLOGIES, LLC 342 E. MAIN STREET SUITE 207 Leola, PA 17540
• 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: 2013-09-26
• Decision Date: 2014-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10866618000033	K133037	000