XiVE® 26-1740
by Dentsply Implants Manufacturing GmbH
Ref 26-1740
XiVE® 26-1740 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-07392532224300) and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 07392532224300), active as of 7 Nov 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-07392532224300 07392532224300 | Date23 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07392532224300 | Date14 Jul 2022 | StatusListed |
Official records
- EUDAMED public site B-07392532224300
- AccessGUDID record 07392532224300
Across registries
- EUDAMED Basic UDI-DI B-07392532224300 registered 23 Oct 2026 Active
- FDA GUDID UDI-DI 07392532224300 listed 14 Jul 2022 Listed
Timeline
- Listed FDA GUDID 07392532224300
- Registered EUDAMED B-07392532224300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- XiVE® Twist Drill Crestal D3.8 EUDAMEDXiVE® GUDID
- Generic name
- Fixture/appliance dental drill bit, reusable
- Model / Ref / Catalog
- 26-1740
- Primary DI / UDI-DI
- 07392532224300
- Basic UDI-DI
- B-07392532224300
- FDA product code
- NDP
- EMDN code
- P01020180 Dental implants - accessories
- GMDN term
- Fixture/appliance dental drill bit, reusable
- Device class
- Class IIa EUDAMEDClass 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
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
| Supplied sterile | Yes | No |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Supplied sterile UDI-DI 07392532224300: EUDAMED states Yes, FDA GUDID states No.
- Sterilise before use UDI-DI 07392532224300: 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.
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