Skip to content

Na Rt-Spline

by ZimVie US Corp LLC

Ref RT-SPLINE

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868A4GY Basic UDI-DI 00844868040842UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868040842 UDI-DI Date5 Sep 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Spline®
Generic Name
Dental implant x-ray template
Device Name
Dental Implant Transparencies
Model / Reference
RT-SPLINE
Primary DI / UDI-DI
00844868040842
Basic UDI-DI
844868A4GY
FDA Product Code
HWT
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental implant x-ray template
Device Class
Class I
Regulation Number
888.4800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant x-ray template

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No