510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212961Substantially Equivalent

Smilers

Biotech Dental Smilers, SAS, Salon De Provence, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212961 is the FDA 510(k) clearance record for SMILERS, a class II device, cleared for Biotech Dental Smilers, Sas on under FDA product code NXC (Aligner, Sequential). FDA's definition for product code NXC reads: "The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion". FDA records list one 510(k) clearance for Biotech Dental Smilers, Sas. As of , FDA records show no recalls naming K212961.

Clearance record

Decision date
Received
(4 days to decision)
Product code
NXC Aligner, Sequential
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Biotech Dental Smilers, Sas 305, Allée De Craponne, Salon De Provence, FR
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code NXC

Trailing 12 months
6 clearances under product code NXC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NXC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260