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NobelProcera® IOS Model Implant Replica CC WP

by Nobel Biocare AB EUDAMEDGUDID

Active European Union

Ref 38191

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73327470000002036S Basic UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747175967 UDI-DIDate22 Jul 2022ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
NobelProcera® IOS Model Implant Replica CC WP EUDAMED
NobelProcera® GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
Lab tools for prosthetics
Model / Ref / Catalog
38191
Primary DI / UDI-DI
07332747175967
Basic UDI-DI
73327470000002036S
FDA Product Code
NDP
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Sweden
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
SE-MF-000000009

Related devices

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

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No