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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K203712
Device Name The Slide
Applicant
Biotex, Inc.
114 Holmes Rd.
Houston,  TX  77045
Applicant Contact Wade Munsch
Correspondent
Biotex, Inc.
114 Holmes Rd.
Houston,  TX  77045
Correspondent Contact Wade Munsch
Regulation Number872.5570
Classification Product Code
LQZ  
Subsequent Product Code
LRK  
Date Received12/21/2020
Decision Date 07/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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