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XiVE® 26-1610

by Dentsply Implants Manufacturing GmbH

Ref 26-1610

XiVE® 26-1610 is a Class I device made by Dentsply Implants Manufacturing GmbH, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 739253200049D9) and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 07392532224096), 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 Number739253200049D9 Basic UDI-DI 07392532224096UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07392532224096 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 739253200049D9 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 07392532224096 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07392532224096
  2. Registered EUDAMED 739253200049D9

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  • Withdrawn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
XiVE® BoneCondenser straight D2.0 EUDAMED
XiVE® GUDID
Generic name
Dental osteotome
Device name
Xive Surgical Instruments Ir Condenser
Model / Ref / Catalog
26-1610
Primary DI / UDI-DI
07392532224096
Basic UDI-DI
739253200049D9
Direct marketing DI
07392532267338
FDA product code
EMM
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental osteotome
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 07392532224096: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Dental osteotome

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
  • Reusable
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)