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ClearCorrect System MFG-0100 5.0

by ClearCorrect Operating LLC

ClearCorrect System MFG-0100 5.0 (REF-01), an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by ClearCorrect Operating LLC, was listed in FDA GUDID on 8 Apr 2019 (UDI-DI D865REF0001); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD865REF0001 UDI-DI Date8 Apr 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ClearCorrect System
Generic name
Orthodontic progressive aligner
Model / Ref / Catalog
MFG-0100 5.0, REF-01
Primary DI / UDI-DI
D865REF0001
FDA product code
NXC
GMDN term
Orthodontic progressive aligner
Device class
Class II
Regulation number
872.5470
GUDID distribution status
Not in Commercial Distribution

Similar devices

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

Other devices from ClearCorrect Operating LLC

See all devices from ClearCorrect Operating LLC →

Properties

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