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DS OmniTaper 68010013

by Dentsply Implants Manufacturing GmbH

Ref 68010013

DS OmniTaper 68010013 is a dental implant suprastructure (EU MDR Class IIa; FDA Class II; FDA product code NHA, Abutment, implant, dental, endosseous) made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 739253200215D2) and listed in FDA GUDID since 16 Dec 2022 (UDI-DI 07392532279089), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number739253200215D2 Basic UDI-DI 07392532279089UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532279089 UDI-DI Date16 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200215D2 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 07392532279089 listed 16 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532279089
  2. Registered EUDAMED 739253200215D2

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  • Withdrawn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
TempBase Cap (XS)-(M) EUDAMED
DS OmniTaper GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
EV Prosthetics Prosthetic Products IIa Plastic
Model / Ref / Catalog
68010013
Primary DI / UDI-DI
07392532279089
Basic UDI-DI
739253200215D2
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
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 07392532279089: EUDAMED states Yes, FDA GUDID states No.

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: Dental implant suprastructure, temporary, preformed, single-use

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentsply Implants Manufacturing GmbH

See all devices from Dentsply Implants Manufacturing GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Lot / batch number
Other properties (21, all answered No)