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ClearCorrect System Engager Template

by ClearCorrect Operating LLC

Ref REF02

ClearCorrect System Engager Template (REF02), an orthodontic resin positioning tray (EU MDR Class I; FDA Class I; FDA product code QJJ, Indirect Bonding Tray) made by ClearCorrect Operating LLC, was registered in EUDAMED on 28 May 2026 (Basic UDI-DI ++D865CCOrthoAccessoryV4) and listed in FDA GUDID on 25 Aug 2023 (UDI-DI D865REF02001); the registry lists it as withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D865CCOrthoAccessoryV4 Basic UDI-DI D865REF02001UDI-DIDate28 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID NumberD865REF02001 UDI-DI Date25 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D865CCOrthoAccessoryV4 registered 28 May 2026 Withdrawn
  • FDA GUDID UDI-DI D865REF02001 listed 25 Aug 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID D865REF02001
  2. Registered EUDAMED ++D865CCOrthoAccessoryV4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ClearCorrect System Engager Template EUDAMED
ClearCorrect System GUDID
Generic name
Orthodontic resin positioning tray
Device name
ClearCorrect System Accessory
Model / Ref / Catalog
REF02, Engager Template
Primary DI / UDI-DI
D865REF02001
Basic UDI-DI
++D865CCOrthoAccessoryV4
FDA product code
QJJ
EMDN code
Q010499 Orthodontic devices - other
GMDN term
Orthodontic resin positioning tray
Device class
Class I
Regulation number
872.5410
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REF02
GUDID
Engager Template

Related devices

Category: Orthodontic resin positioning tray

Similar devices in this category

Other devices filed under ORTHODONTIC DEVICES - OTHER.

Other devices from ClearCorrect Operating LLC

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)