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Orthodontic Anchor Screw

by BioMaterials Korea, Inc. 41 variants

Ref Orthoplant2204T-001Model Special Type

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809744964300 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08809744964300 Basic UDI-DI 08809744964300UDI-DIDate12 Feb 2025RegisteredStatusActive

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 23 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  • Withdrawn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
Orthodontic Anchor Screw EUDAMED
ACR Orthodontic Anchor Screw GUDID
Generic Name
Orthodontic anchoring screw
Device Name
Orthoplant2204T
Model / Reference
Special Type EUDAMED
Orthoplant2204T-001 EUDAMED
Orthoplant2204T GUDID
Primary DI / UDI-DI
08809744964300
Basic UDI-DI
B-08809744964300
510(k) Number
FDA Product Code
OAT
EMDN Code
Q010499 Orthodontic devices - other
GMDN Term
Orthodontic anchoring screw
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3640
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Special Type
Orthoplant2204T-001
GUDID
Orthoplant2204T
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
KR-MF-000019882
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BioMaterials Korea, Inc.

See all devices from BioMaterials Korea, Inc. →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No