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Neodent 116.289

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

Part of a family of 60 devices: see the family page

Ref 116.289Model Abutment

Neodent 116.289 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 6 May 2026 (Basic UDI-DI 987800045VM), cleared under FDA 510(k) K201491 on 22 Dec 2020 and listed in FDA GUDID since 10 Aug 2023 (UDI-DI 07899878044703), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201491

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800045VM Basic UDI-DI 07899878044703UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878044703 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201491 Date22 Dec 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 987800045VM registered 6 May 2026 Active
  • FDA 510(k) K201491 decided 22 Dec 2020 Active
  • FDA GUDID UDI-DI 07899878044703 listed 10 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201491
  2. Listed FDA GUDID 07899878044703
  3. Registered EUDAMED 987800045VM

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Neodent
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Implant-Abutment Screws
Model / Ref / Catalog
116.289, Abutment
Primary DI / UDI-DI
07899878044703
Basic UDI-DI
987800045VM
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K201491)

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

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
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)