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K3Pro XP-Line Temporärer AufbauKnochenprofiel Schraube

by Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

Ref BPS.XP 35020/3Model K3Pro XP Bone Profile Screw Ø3,5 x KPT 2mm

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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/MDD EUDAMED NumberB-EAGNBPSXP3502030 Basic UDI-DI EAGNBPSXP3502030UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEAGNBPSXP3502030 UDI-DI Date12 Nov 2024ListedStatusListed GUDID: 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
K3Pro XP-Line Temporärer AufbauKnochenprofiel Schraube EUDAMED
K3Pro Konus Dental Implants GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Ref / Catalog
K3Pro XP Bone Profile Screw Ø3, 5 x KPT 2mm, BPS.XP 35020/3
Primary DI / UDI-DI
EAGNBPSXP3502030
Basic UDI-DI
B-EAGNBPSXP3502030
510(k) Number
FDA Product Code
NDP
EMDN Code
P01020101 Dental implants
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000012472

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No