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Neodent 108.012

by JJGC Indústria e Comércio de Materiais Dentários S/A.

Part of a family of 64 devices: see the family page

Ref 108.012Model Instrument

Neodent 108.012 is a device classified as Class IIa in the EU and Class I in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800082VT) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 07898237565552), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800082VT Basic UDI-DI 07898237565552UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07898237565552 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 987800082VT registered 8 May 2026 Active
  • FDA GUDID UDI-DI 07898237565552 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07898237565552
  2. Registered EUDAMED 987800082VT

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  • Withdrawn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
Neodent
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Implant Impression Copings
Model / Ref / Catalog
108.012, Instrument
Primary DI / UDI-DI
07898237565552
Basic UDI-DI
987800082VT
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from JJGC Indústria e Comércio de Materiais Dentários S/A.

See all devices from JJGC Indústria e Comércio de Materiais Dentários S/A. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)