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IC100

by ZimVie US Corp LLC

Part of a family of 99 devices: see the family page

Ref IC100

IC100 is a Class I device made by ZimVie US Corp LLC, registered in EUDAMED on 26 May 2026 (Basic UDI-DI 844868ACHU) and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 00844868004226), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868ACHU Basic UDI-DI 00844868004226UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844868004226 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868ACHU registered 26 May 2026 Active
  • FDA GUDID UDI-DI 00844868004226 listed 6 Oct 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844868004226
  2. Registered EUDAMED 844868ACHU

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  • Withdrawn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

Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Dental Transfers, Impression Caps and Impression Copings
Model / reference
IC100
Primary DI / UDI-DI
00844868004226
Basic UDI-DI
844868ACHU
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)