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XiVE® 26-5402

by Dentsply Implants Manufacturing GmbH

Ref 26-5402

XiVE® 26-5402 is a device classified as Class IIa in the EU and Class I in the US made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-07392532225857) and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 07392532225857), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-07392532225857 Basic UDI-DI 07392532225857UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532225857 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07392532225857 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 07392532225857 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532225857
  2. Registered EUDAMED B-07392532225857

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
XiVE® Initial Drill GS D3.8 EUDAMED
XiVE® GUDID
Generic name
Fixture/appliance dental drill bit, reusable
Model / Ref / Catalog
26-5402
Primary DI / UDI-DI
07392532225857
Basic UDI-DI
B-07392532225857
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 07392532225857: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fixture/appliance dental drill bit, reusable

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
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)