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Voodoo Clear Aligners 1

by Voodoo Manufacturing, Inc.

Voodoo Clear Aligners 1 is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Voodoo Manufacturing, Inc., cleared under FDA 510(k) K190948 on 9 May 2019 and listed in FDA GUDID since 9 Jul 2019 (UDI-DI 00860000937801), 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) K190948

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 Number00860000937801 UDI-DI Date9 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190948 Date9 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190948 decided 9 May 2019 Active
  • FDA GUDID UDI-DI 00860000937801 listed 9 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190948
  2. Listed FDA GUDID 00860000937801

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Voodoo Clear Aligners
Generic name
Orthodontic progressive aligner
Model / reference
1
Primary DI / UDI-DI
00860000937801
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 (K190948)

and 8 more cleared under K190948

Similar devices

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

Other devices from Voodoo Manufacturing, Inc.

Properties

  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)