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K3Pro Implant/abutment screws

by Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG 15 variants

Ref FLA_AS1.6Model Orthodontic Finder/ Locator Abutment screw

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-EAGNFLAAS160 Basic UDI-DI EAGNFLAAS160UDI-DIDate24 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberEAGNFLAAS160 UDI-DI Date22 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  • Withdrawn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 Implant/abutment screws EUDAMED
K3Pro Konus Dental Implants GUDID
Generic Name
Dental prosthesis/implant abutment screw
Model / Ref / Catalog
Orthodontic Finder/ Locator Abutment screw, FLA_AS1.6
Primary DI / UDI-DI
EAGNFLAAS160
Basic UDI-DI
B-EAGNFLAAS160
510(k) Number
FDA Product Code
NDP
EMDN Code
P01020101 Dental implants
GMDN Term
Dental prosthesis/implant abutment screw
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
DE-MF-000012472

Other devices from Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG

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Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number

Other properties (18)

  • Sterile: No
  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No