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Impression Coping BDICTRB6012

by Megagen Implant Co. Ltd

Ref BDICTRB6012T

Impression Coping BDICTRB6012 (BDICTRB6012T) is a Class I device made by Megagen Implant Co. Ltd, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI 880972899231PZ) and listed in FDA GUDID since 4 Jul 2023 (UDI-DI 08809822765010), active as of 25 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899231PZ Basic UDI-DI 08809822765010UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809822765010 UDI-DI Date4 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880972899231PZ registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 08809822765010 listed 4 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809822765010
  2. Registered EUDAMED 880972899231PZ

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  • Withdrawn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
Impression Coping
Generic name
Dental precision attachment simulator/analog, single-use
Device name
Impression
Model / Ref / Catalog
BDICTRB6012T, BDICTRB6012
Description
BLUEDIAMOND Implant System Ø6/ C3/ L12/ Transfer/ RC/ Bridge [8Ncm]
Primary DI / UDI-DI
08809822765010
Basic UDI-DI
880972899231PZ
FDA product code
NDP
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
GMDN term
Dental precision attachment simulator/analog, single-use
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BDICTRB6012T
GUDID
BDICTRB6012

Related devices

Category: Dental precision attachment simulator/analog, single-use

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)