FDA 510(k)

SMILERS

K-Number: K212961 · 2021-09-20

Decision Date2021-09-20

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SMILERS is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Dental Smilers, Sas. It received FDA 510(k) clearance on 2021-09-20 under 510(k) 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. The listed applicant is Biotech Dental Smilers, Sas. The 510(k) number is K212961.

When did SMILERS receive FDA 510(k) clearance?

SMILERS received FDA 510(k) clearance on 2021-09-20, under 510(k) number K212961.

Who is the listed applicant for SMILERS?

The FDA 510(k) record lists Biotech Dental Smilers, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMILERS?

The FDA product code for SMILERS is NXC.

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

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.