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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K212068
Device Name Biotech Dental Kits
Applicant
Biotech Dental, Sas
305 Allées De Craponne
Salon De Provence,  FR 13300
Applicant Contact Delphine Mercier
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/02/2021
Decision Date 11/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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