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Spline® 1657

by ZimVie US Corp LLC

Part of a family of 49 devices: see the family page

Ref 1657

Spline® 1657 is a Class I device made by ZimVie US Corp LLC, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 844868ABHS) and listed in FDA GUDID since 10 Feb 2017 (UDI-DI 00889024012325), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number844868ABHS Basic UDI-DI 00889024012325UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024012325 UDI-DI Date10 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868ABHS registered 28 May 2026 Active
  • FDA GUDID UDI-DI 00889024012325 listed 10 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024012325
  2. Registered EUDAMED 844868ABHS

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  • Withdrawn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 suprastructure, temporary, preformed, single-use
Device name
Dental Laboratory Tools
Model / reference
1657
Primary DI / UDI-DI
00889024012325
Basic UDI-DI
844868ABHS
FDA product code
NDP
EMDN code
Q0199 Odontology devices - 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
Sterilisation method
Moist Heat or Steam Sterilization

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 ODONTOLOGY DEVICES - OTHER.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)