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On1 Prosthetic Lab Screw NP/RP/WP

by Nobel Biocare AB 2 variants

Ref 38751

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73327470000002026Q Basic UDI-DI 07332747176285UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07332747176285 UDI-DI Date22 Jul 2022ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
On1 Prosthetic Lab Screw NP/RP/WP EUDAMED
On1™ GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, reusable
Device Name
Reusable lab tools for prosthetics
Model / Ref / Catalog
38751
Primary DI / UDI-DI
07332747176285
Basic UDI-DI
73327470000002026Q
FDA Product Code
NDP
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental implant suprastructure, temporary, preformed, reusable
Device Class
Class I
Regulation Number
872.3980
EU 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

Other devices from Nobel Biocare AB

See all devices from Nobel Biocare AB →

Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: 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