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Twist Drill TDE2013LC01

by OSSTEM IMPLANT Co., Ltd.

Ref T02TAM4745NTH

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 Number88000406ABUTMENTRZ Basic UDI-DI 08809917071521UDI-DIDate26 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809917071521 UDI-DI Date1 Nov 2023ListedStatusListed 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  • Withdrawn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
T02 Two Abutment Set EUDAMED
Twist Drill GUDID
Generic Name
Fixture/appliance dental drill bit, reusable
Device Name
Dental Abutment System
Model / Reference
T02TAM4745NTH EUDAMED
TDE2013LC01 GUDID
Primary DI / UDI-DI
08809917071521
Basic UDI-DI
88000406ABUTMENTRZ
FDA Product Code
DZA
EMDN Code
P01020101 Dental implants
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class IIb EUDAMED
Class I GUDID
Regulation Number
872.4130
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
T02TAM4745NTH
GUDID
TDE2013LC01
Device ClassEUDAMED
Class IIb
GUDID
Class I
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Fixture/appliance dental drill bit, reusable

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No