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Neodent 110.317

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

Part of a family of 17 devices: see the family page

Ref 110.318Model Instrument

Neodent 110.317 is a device classified as Class IIa in the EU and Class II in the US made by JJGC Indústria e Comércio de Materiais Dentários S/A., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 987800085VZ), cleared under FDA 510(k) K223662 on 20 Apr 2023 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 07899878058298), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223662

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number987800085VZ Basic UDI-DI 07899878058298UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878058298 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223662 Date20 Apr 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 987800085VZ registered 8 May 2026 Active
  • FDA 510(k) K223662 decided 20 Apr 2023 Active
  • FDA GUDID UDI-DI 07899878058298 listed 15 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223662
  2. Listed FDA GUDID 07899878058298
  3. Registered EUDAMED 987800085VZ

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  • Withdrawn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
Instrument tray, reusable
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name
Complete Surgical Kits
Model / Ref / Catalog
110.318, Instrument, 110.317
Primary DI / UDI-DI
07899878058298, 07899878058281
Basic UDI-DI
987800085VZ
510(k) Number
FDA product code
KCT
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Instrument tray, reusable
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Instrument tray, reusable

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - 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
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)