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Elos Accurate® Hexalobular Prosthetic Screw AS-DBAM1605A-1

by Elos Medtech Pinol A/S

Ref AS-DBAM1605A-1

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

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5712821006001V5 Basic UDI-DI 05712821002297UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05712821002297 UDI-DI Date31 Mar 2020ListedStatusListed 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.

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  • Withdrawn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
Elos Accurate® Hexalobular Prosthetic Screw
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
Elos Prosthetic Screw
Model / Reference
AS-DBAM1605A-1
Primary DI / UDI-DI
05712821002297
Basic UDI-DI
5712821006001V5
FDA Product Code
NDP
EMDN Code
P01020101 Dental implants
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
872.3980
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class I

Related devices

Category: Dental implant suprastructure, permanent, preformed

Other devices from Elos Medtech Pinol A/S

See all devices from Elos Medtech Pinol A/S →

Properties

  • Single Use
  • Implantable
  • Sutures
  • 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