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SwissPlus® SPGA

by ZimVie US Corp LLC

Part of a family of 105 devices: see the family page

Ref SPGA

SwissPlus® SPGA is a device classified as Class IIb in the EU and Class II in the US made by ZimVie US Corp LLC, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 844868FGJK) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00889024017412), 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 Number844868FGJK Basic UDI-DI 00889024017412UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024017412 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 844868FGJK registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 00889024017412 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024017412
  2. Registered EUDAMED 844868FGJK

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  • Withdrawn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
Tapered SwissPlus® Abutment and Components EUDAMED
SwissPlus® GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Friction-Fit Definitive Abutment
Model / reference
SPGA
Primary DI / UDI-DI
00889024017412
Basic UDI-DI
844868FGJK
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
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 · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00889024017412: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 00889024017412: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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 IMPLANTS.

Other devices from ZimVie US Corp LLC

See all devices from ZimVie US Corp LLC →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)