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Unismile Clear Aligner Full Package

by Vitang Technology LLC

Unismile Clear Aligner Full Package is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Vitang Technology LLC, cleared under FDA 510(k) K191837 on 29 Jan 2020 and listed in FDA GUDID since 14 Oct 2024 (UDI-DI 10860012674647), 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) K191837

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 Number10860012674647 UDI-DI Date14 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191837 Date29 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191837 decided 29 Jan 2020 Active
  • FDA GUDID UDI-DI 10860012674647 listed 14 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191837
  2. Listed FDA GUDID 10860012674647

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Unismile Clear Aligner
Generic name
Orthodontic progressive aligner
Model / reference
Full Package
Primary DI / UDI-DI
10860012674647
510(k) Number
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic progressive aligner

Cleared under the same submission (K191837)

Similar devices

Other devices filed under FDA product code NXC (Aligner, Sequential).

Other devices from Vitang Technology LLC

See all devices from Vitang Technology LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)