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Neodent 109.947

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

Part of a family of 109 devices: see the family page

Ref 109.947Model IMPLANT

Neodent 109.947 is a device classified as Class IIb in the EU and Class II in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 987800047VR) and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 07899878024187), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800047VR Basic UDI-DI 07899878024187UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878024187 UDI-DI Date18 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 987800047VR registered 27 May 2026 Active
  • FDA GUDID UDI-DI 07899878024187 listed 18 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899878024187
  2. Registered EUDAMED 987800047VR

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  • Withdrawn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
Screw endosteal dental implant, one-piece
Device name
Helix Implant
Model / Ref / Catalog
109.947, IMPLANT
Description
GM HELIX IMPLANT
Primary DI / UDI-DI
07899878024187
Basic UDI-DI
987800047VR
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3.5 Millimeter
Length — 16 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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

Related devices

Category: Screw endosteal dental implant, one-piece

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)