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Smilers Aligner

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212961

by Biotech Dental Smilers

Identifiers

510(k) Number
K212961 FDA 510(k)
FDA Product Code
NXC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.5470 FDA 510(k)
Regulation Number
872.5470 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Smilers Aligner is a custom-made, Class IIa medical device designed for sequential dental alignment. It consists of transparent thermoplastic aligners used to gradually reposition teeth into desired positions, addressing orthodontic concerns through a series of incremental adjustments.

These aligners are supplied as single-use, sterile devices tailored to individual patient needs. They are intended for use in dental offices and require proper storage under controlled conditions to maintain sterility. The device is regulated under FDA 510K clearance (K212961) and complies with regulation number 872.5470, with no specific MRI safety restrictions noted.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SMILERS - Biotech Dental, Home - Smilers® clear aligners - Smilers, Smilers® Expert - Biotech Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotech Dental Smilers
FDA Applicant
Biotech Dental Smilers, Sas

Sources (1)

  • FDA 510(k) K212961 24 fields · synced Sep 19, 2026