Skip to content

Neodent 128.035

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

Part of a family of 16 devices: see the family page

Ref 128.035Model Instrument

Neodent 128.035 is a Class I device made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800057VU) and listed in FDA GUDID since 13 Dec 2022 (UDI-DI 07899878054399), 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 Number987800057VU Basic UDI-DI 07899878054399UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878054399 UDI-DI Date13 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 987800057VU registered 8 May 2026 Active
  • FDA GUDID UDI-DI 07899878054399 listed 13 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899878054399
  2. Registered EUDAMED 987800057VU

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  • Withdrawn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 implantation depth/angle gauge, reusable
Device name
Devices for aid dental procedures
Model / Ref / Catalog
128.035, Instrument
Primary DI / UDI-DI
07899878054399
Basic UDI-DI
987800057VU
FDA product code
NDP
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implantation depth/angle gauge, reusable
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 07899878054399: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Dental implantation depth/angle gauge, reusable

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - 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
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)