Biotech Dental Kits

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Biotech Dental, SAS

The following data is part of a premarket notification filed by Biotech Dental, Sas with the FDA for Biotech Dental Kits.

Pre-market Notification Details

Device IDK212068
510k NumberK212068
Device Name:Biotech Dental Kits
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Biotech Dental, SAS 305 Allées De Craponne Salon De Provence,  FR 13300
ContactDelphine Mercier
CorrespondentMelissa Burbage
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2021-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03701045244714 K212068 000
03701045243526 K212068 000
03701045243540 K212068 000
03701045243618 K212068 000
03701045243694 K212068 000
03701045243700 K212068 000
03701045245032 K212068 000
03701045245049 K212068 000
03701045270645 K212068 000
03701045270652 K212068 000
03701045240181 K212068 000
03701045240525 K212068 000
03701045240709 K212068 000
03701045243762 K212068 000
03701045243779 K212068 000
03701045243786 K212068 000
03701045244707 K212068 000
03701045243519 K212068 000

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