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ClearCorrect System Engager Template REF06

by ClearCorrect Operating LLC

Ref REF06

ClearCorrect System Engager Template REF06 is an orthodontic resin positioning tray (EU MDR Class I; FDA Class I; FDA product code QJJ, Indirect Bonding Tray) made by ClearCorrect Operating LLC, registered in EUDAMED on 28 May 2026 (Basic UDI-DI ++D865CCOrthoAccessoryV4) and listed in FDA GUDID since 2 Feb 2024 (UDI-DI D865REF06001), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

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 D865REF06001UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD865REF06001 UDI-DI Date2 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D865CCOrthoAccessoryV4 registered 28 May 2026 Active
  • FDA GUDID UDI-DI D865REF06001 listed 2 Feb 2024 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 D865REF06001
  2. Registered EUDAMED ++D865CCOrthoAccessoryV4

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ClearCorrect System Engager Template
Generic name
Orthodontic resin positioning tray
Device name
ClearCorrect System Accessory
Model / Ref / Catalog
REF06
Primary DI / UDI-DI
D865REF06001
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)