SMILERS
K-Number: K212961 · 2021-09-20
ApplicantBiotech Dental Smilers, Sas
Decision Date2021-09-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SMILERS is a medical device manufactured by Biotech Dental Smilers, Sas. It received FDA 510(k) clearance on 2021-09-20 under approval number K212961. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SMILERS?
SMILERS is a medical device that received FDA 510(k) clearance on 2021-09-20. It is manufactured by Biotech Dental Smilers, Sas. The 510(k) number is K212961.
When was SMILERS approved by the FDA?
SMILERS received FDA 510(k) clearance on 2021-09-20, under approval number K212961.
What company makes SMILERS?
SMILERS is manufactured by Biotech Dental Smilers, Sas.
What is the FDA product code for SMILERS?
The FDA product code for SMILERS is NXC.
Related Devices (Code: NXC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.