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Neobiotech Implant System TP45

by Neobiotech. co., ltd

Ref TP45

Neobiotech Implant System TP45 is a device classified as Class IIa in the EU and Class I in the US made by Neobiotech. co., ltd, registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI B-08809407159388) and listed in FDA GUDID since 28 Nov 2022 (UDI-DI 08809407159388), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809407159388 Basic UDI-DI 08809407159388UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809407159388 UDI-DI Date28 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809407159388 registered 10 Jun 2026 Active
  • FDA GUDID UDI-DI 08809407159388 listed 28 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809407159388
  2. Registered EUDAMED B-08809407159388

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  • Withdrawn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
Tissue Punch EUDAMED
Neobiotech Implant System GUDID
Generic name
Fixture/appliance dental drill bit, reusable
Model / reference
TP45
Primary DI / UDI-DI
08809407159388
Basic UDI-DI
B-08809407159388
FDA product code
NDP
EMDN code
P01020101 Dental implants
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Neobiotech Co., Ltd.

See all devices from Neobiotech Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (16, all answered No)