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Smilers Retainer Appliance

by Biotech Dental Smilers

Smilers Retainer Appliance (GOUTC) is an orthodontic retainer (FDA Class I; FDA product code KMY, Positioner, Tooth, Preformed) made by Biotech Dental Smilers, cleared under FDA 510(k) K212961 on 20 Sep 2021 and listed in FDA GUDID since 20 Apr 2022 (UDI-DI 03770020010057), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K212961

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770020010057 UDI-DI Date20 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212961 Date20 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212961 decided 20 Sep 2021 Active
  • FDA GUDID UDI-DI 03770020010057 listed 20 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212961
  2. Listed FDA GUDID 03770020010057

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Smilers
Generic name
Orthodontic retainer
Model / Ref / Catalog
Retainer Appliance, GOUTC
Primary DI / UDI-DI
03770020010057
510(k) Number
FDA product code
KMY
GMDN term
Orthodontic retainer
Device class
Class I
Regulation number
872.5525
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Orthodontic retainer

Cleared under the same submission (K212961)

and 4 more cleared under K212961

Similar devices in this category

Other devices filed under Orthodontic retainer.

Other devices from Biotech Dental Smilers

See all devices from Biotech Dental Smilers →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)