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K3Pro Rapid / R-Line Implant

by Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG 24 variants

Ref 40013K3PRO.RModel 4.0 x 13.0mm K3Pro "Rapid" lmplant with 3mm Platform

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-EAGN40013K3PROR0 Basic UDI-DI EAGN40013K3PROR0UDI-DIDate27 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberEAGN40013K3PROR0 UDI-DI Date12 Sep 2016ListedStatusListed 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  • Withdrawn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 Rapid / R-Line Implant EUDAMED
K3Pro Konus Dental Implants GUDID
Generic Name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
4.0 x 13.0mm K3Pro "Rapid" lmplant with 3mm Platform, 40013K3PRO.R
Primary DI / UDI-DI
EAGN40013K3PROR0 EUDAMED
EAGN40013K3PROR9 GUDID
Basic UDI-DI
B-EAGN40013K3PROR0
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020101 Dental implants
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 13 Millimeter
Outer Diameter — 4 Millimeter
Lumen/Inner Diameter — 3 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
EAGN40013K3PROR0
GUDID
EAGN40013K3PROR9
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000012472

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Manufacturing Date: No