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123-Smile Spanish

by U Smile Dental LLC

123-Smile Spanish is a Class II device made by U Smile Dental LLC, cleared under FDA 510(k) K133071 on 28 May 2014 and listed in FDA GUDID since 5 Jun 2021 (UDI-DI 00860006415495), active as of 22 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 22 Oct 2026

Documents

510(k) K133071

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860006415495 UDI-DI Date5 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133071 Date28 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133071 decided 28 May 2014 Active
  • FDA GUDID UDI-DI 00860006415495 listed 5 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133071
  2. Listed FDA GUDID 00860006415495

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
123-Smile
Generic name
Dental impression material kit, single-use
Model / reference
Spanish
Primary DI / UDI-DI
00860006415495
510(k) Number
FDA product code
ELW
GMDN term
Dental impression material kit, single-use
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental impression material kit, single-use

Cleared under the same submission (K133071)

and 8 more cleared under K133071

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

Other devices from U Smile Dental LLC

Properties

  • Single use
  • Convenience kit
Other properties (13, all answered No)