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DS Implants 68012240

by Dentsply Implants Manufacturing GmbH

Ref 68012240

DS Implants 68012240 is a dental implant suprastructure (EU MDR Class I; FDA Class I; FDA product code NDP, Accessories, implant, dental, endosseous) made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 739253200208D5) and listed in FDA GUDID since 1 Jul 2022 (UDI-DI 07392532261428), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number739253200208D5 Basic UDI-DI 07392532261428UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532261428 UDI-DI Date1 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200208D5 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 07392532261428 listed 1 Jul 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 07392532261428
  2. Registered EUDAMED 739253200208D5

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  • Withdrawn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
MultiBase Burnout Cylinder EUDAMED
DS Implants GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
EV Prosthetics Laboratory Products I BurnOuts
Model / Ref / Catalog
68012240
Primary DI / UDI-DI
07392532261428
Basic UDI-DI
739253200208D5
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
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 07392532261428: EUDAMED states Yes, FDA GUDID states No.

Related devices

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

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Dentsply Implants Manufacturing GmbH

See all devices from Dentsply Implants Manufacturing GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)