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FDA 510(k)

Biotech Dental Kits

K-Number: K212068 · 2021-11-08

Decision Date2021-11-08
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biotech Dental Kits is a medical device manufactured by Biotech Dental, Sas. It received FDA 510(k) clearance on 2021-11-08 under approval number K212068. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biotech Dental Kits?

Biotech Dental Kits is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Biotech Dental, Sas. The 510(k) number is K212068.

When was Biotech Dental Kits approved by the FDA?

Biotech Dental Kits received FDA 510(k) clearance on 2021-11-08, under approval number K212068.

What company makes Biotech Dental Kits?

Biotech Dental Kits is manufactured by Biotech Dental, Sas.

What is the FDA product code for Biotech Dental Kits?

The FDA product code for Biotech Dental Kits is KCT.

Other Devices by Biotech Dental, Sas

Related Devices (Code: KCT)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.