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AnyOne Internal Fixture IF5507D

by Megagen Implant Co. Ltd 2 variants

Ref IF5507DC

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880972899208Q6 Basic UDI-DI 08806388221165UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806388221165 UDI-DI Date25 Jun 2015ListedStatusListed 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 24 Oct 2026.

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  • Withdrawn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
AnyOne Internal Fixture
Generic name
Screw endosteal dental implant, two-piece
Model / Ref / Catalog
IF5507DC, IF5507D
Description
AnyOne Internal Ø5.5/ L=7/ DT
Primary DI / UDI-DI
08806388221165
Basic UDI-DI
880972899208Q6
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 registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
IF5507DC
GUDID
IF5507D
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Screw endosteal dental implant, two-piece

Cleared under the same submission (K123988)

Show all (12)

Other devices from Megagen Implant Co., Ltd.

See all devices from Megagen Implant Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No