SmileGuard

Mouthguard, Prescription

EnvisionTEC GmbH

The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for Smileguard.

Pre-market Notification Details

• Device ID: K220894
• 510k Number: K220894
• Device Name: SmileGuard
• Classification: Mouthguard, Prescription
• Applicant: EnvisionTEC GmbH Brusseler Straße 51 Gladbeck, DE D-45968
• Contact: Ruediger Van Bernum
• Correspondent: Patsy J Trisler; Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250
• 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: 2022-03-28
• Decision Date: 2022-06-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260683220652	K220894	000