Skip to content

XiVE® 26-1025

by Dentsply Implants Manufacturing GmbH

Ref 26-1025

XiVE® 26-1025 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 23 Oct 2026 (Basic UDI-DI B-07392532212079) and listed in FDA GUDID since 21 Dec 2023 (UDI-DI 07392532212079), 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-07392532212079 Basic UDI-DI 07392532212079UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532212079 UDI-DI Date21 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07392532212079 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 07392532212079 listed 21 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532212079
  2. Registered EUDAMED B-07392532212079

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  • Withdrawn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® Single-Patient-Drill D3.0/L8-15 EUDAMED
XiVE® GUDID
Generic name
Fixture/appliance dental drill bit, single-use
Model / reference
26-1025
Primary DI / UDI-DI
07392532212079
Basic UDI-DI
B-07392532212079
FDA product code
NDP
EMDN code
P01020180 Dental implants - accessories
GMDN term
Fixture/appliance dental drill bit, single-use
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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, 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

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)