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Burn-Out Cylinder AANBCS570

by Megagen Implant Co. Ltd EUDAMEDGUDID

Active European Union

Ref AANBCS570

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899233Q5 Basic UDI-DIDate20 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388200986 UDI-DIDate23 Jun 2015ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Burn-Out Cylinder
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
AANBCS570
Description
AnyRidge Internal Ø5/ Single
Primary DI / UDI-DI
08806388200986
Basic UDI-DI
880972899233Q5
510(k) Number
FDA Product Code
NHA
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3630
Market of Registration
Netherlands
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 I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K110955)

Show all (12)

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Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial 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
  • Premarket Exempt: No
  • Expiration Date: No