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Neodent 103.091

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

Ref 103.091Model Instrument

Neodent 103.091 is a dental drill bit extension (EU MDR Class IIa; FDA Class I; FDA product code DZA, Drill, Dental, Intraoral) made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800134VM) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 07898237561516), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800134VM Basic UDI-DI 07898237561516UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07898237561516 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 987800134VM registered 8 May 2026 Active
  • FDA GUDID UDI-DI 07898237561516 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07898237561516
  2. Registered EUDAMED 987800134VM

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  • Withdrawn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 drill bit extension
Device name
Drilling Instruments
Model / Ref / Catalog
103.091, Instrument
Primary DI / UDI-DI
07898237561516
Basic UDI-DI
987800134VM
FDA product code
DZA
EMDN code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
GMDN term
Dental drill bit extension
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4130
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07898237561516: EUDAMED states Yes, FDA GUDID states No.

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 drill bit extension

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)