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Neodent 110316

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

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

Ref 110.316Model Instrument

Neodent 110316 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) K214051 on 13 Apr 2022 and listed in FDA GUDID since 3 May 2022 (UDI-DI 07899878056348), 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) K214051

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 07899878056348UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899878056348 UDI-DI Date3 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK214051 Date13 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 987800085VZ registered 8 May 2026 Active
  • FDA 510(k) K214051 decided 13 Apr 2022 Active
  • FDA GUDID UDI-DI 07899878056348 listed 3 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K214051
  2. Listed FDA GUDID 07899878056348
  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  • Withdrawn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
Device name
Complete Surgical Kits
Model / Ref / Catalog
Instrument EUDAMED
110.316 EUDAMED
110316 GUDID
Primary DI / UDI-DI
07899878056348
Basic UDI-DI
987800085VZ
510(k) Number
FDA product code
KCT
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Instrument tray, 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
Size
Length — 195 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Instrument
110.316
GUDID
110316
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

Cleared under the same submission (K214051)

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)