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Eztetic™ CASLC

by ZimVie US Corp LLC

Ref CASLC

Eztetic™ CASLC is a device classified as Class I in the EU and Class II in the US made by ZimVie US Corp LLC, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 844868A7H6) and listed in FDA GUDID since 3 Mar 2016 (UDI-DI 00889024343184), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868A7H6 Basic UDI-DI 00889024343184UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024343184 UDI-DI Date3 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868A7H6 registered 22 May 2026 Active
  • FDA GUDID UDI-DI 00889024343184 listed 3 Mar 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024343184
  2. Registered EUDAMED 844868A7H6

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  • Withdrawn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
Eztetic® EUDAMED
Eztetic™ GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Transfer Screws and Try-in Screws
Model / reference
CASLC
Primary DI / UDI-DI
00889024343184
Basic UDI-DI
844868A7H6
FDA product code
DZE
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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

Related devices

Category: Dental implant suprastructure, permanent, preformed

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)