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Cervical Matrix 0005040000

by Tdv Dental Ltda

Part of a family of 8 devices: see the family page

Ref 0005040000Model CERVICAL MATRIX

Cervical Matrix 0005040000 is a Class I device made by Tdv Dental Ltda, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 7897990300504JF) and listed in FDA GUDID since 28 Feb 2025 (UDI-DI 07897990342103), 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 Number7897990300504JF Basic UDI-DI 07897990342103UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07897990342103 UDI-DI Date28 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7897990300504JF registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 07897990342103 listed 28 Feb 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07897990342103
  2. Registered EUDAMED 7897990300504JF

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  • Withdrawn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
Cervical Matrix
Generic name
Dental spatula, reusable
Model / Ref / Catalog
0005040000, CERVICAL MATRIX
Primary DI / UDI-DI
07897990342103
Basic UDI-DI
7897990300504JF
FDA product code
EKF
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental spatula, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07897990342103: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Dental spatula, reusable

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Tdv Dental Ltda

See all devices from Tdv Dental Ltda →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)