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Excellent Solid Driver OTE48L

by OSSTEM IMPLANT Co., Ltd.

Part of a family of 64 devices: see the family page

Ref OTE48L

Excellent Solid Driver OTE48L 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 10 Feb 2026 (Basic UDI-DI 88000406TOOLQD) and listed in FDA GUDID since 1 Nov 2023 (UDI-DI 08809892363734), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406TOOLQD Basic UDI-DI 08809892363734UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809892363734 UDI-DI Date1 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000406TOOLQD registered 10 Feb 2026 Active
  • FDA GUDID UDI-DI 08809892363734 listed 1 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809892363734
  2. Registered EUDAMED 88000406TOOLQD

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  • Withdrawn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
Excellent Solid Driver
Generic name
Surgical screwdriver, reusable
Device name
Tool System
Model / reference
OTE48L
Primary DI / UDI-DI
08809892363734
Basic UDI-DI
88000406TOOLQD
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3980
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.

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from OSSTEM IMPLANT Co., Ltd.

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

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)