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Precision II Implant IRSS3308

by Ebi, Inc.

Ref IRSS3308

Precision II Implant IRSS3308 is a device classified as Class IIb in the EU and Class II in the US made by Ebi, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-08809468050877) and listed in FDA GUDID since 2 Oct 2025 (UDI-DI 08809468050877), active as of 12 Nov 2026.

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

CE MDD

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809468050877 Basic UDI-DI 08809468050877UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809468050877 UDI-DI Date2 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809468050877 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 08809468050877 listed 2 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809468050877
  2. Registered EUDAMED B-08809468050877

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Precision II Implant
Generic name
Screw endosteal dental implant, one-piece
Model / reference
IRSS3308
Primary DI / UDI-DI
08809468050877
Basic UDI-DI
B-08809468050877
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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.

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Ebi, Inc.

See all devices from Ebi, Inc. →

Properties

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