The Slide

Device, Jaw Repositioning

Biotex, Inc.

The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for The Slide.

Pre-market Notification Details

• Device ID: K203712
• 510k Number: K203712
• Device Name: The Slide
• Classification: Device, Jaw Repositioning
• Applicant: Biotex, Inc. 114 Holmes Rd. Houston, TX 77045
• Contact: Wade Munsch
• Correspondent: Wade Munsch; Biotex, Inc. 114 Holmes Rd. Houston, TX 77045
• Product Code: LQZ
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-21
• Decision Date: 2021-07-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M71004610000	K203712	000
M71004615000	K203712	000