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Positioning Guide Full KIT

by OSSTEM IMPLANT Co., Ltd. 2 variants

Part of a family of 74 devices: see the family page

Ref OPGAK

Positioning Guide Full KIT (OPGAK) is a device classified as Class IIa in the EU and Class I in the US made by Osstem Implant Co., Ltd, registered in EUDAMED on 11 Feb 2026 (Basic UDI-DI 88000406DRILLKITSYSTEMD6) and listed in FDA GUDID since 7 Aug 2023 (UDI-DI 08809917110527), active as of 22 Oct 2026.

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

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406DRILLKITSYSTEMD6 Basic UDI-DI 08809917110527UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809917110527 UDI-DI Date7 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000406DRILLKITSYSTEMD6 registered 11 Feb 2026 Active
  • FDA GUDID UDI-DI 08809917110527 listed 7 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809917110527
  2. Registered EUDAMED 88000406DRILLKITSYSTEMD6

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  • Withdrawn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

Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name
Surgical KIT System
Model / reference
OPGAK
Primary DI / UDI-DI
08809917110527
Basic UDI-DI
88000406DRILLKITSYSTEMD6
FDA product code
NYE
EMDN code
L159016 Dental surgery instrument kits, reusable
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Czechia
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.

Manufacturer details

EUDAMED SRN
KR-MF-000020006
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under DENTAL SURGERY INSTRUMENT KITS, REUSABLE.

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant Co., Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)