Simple Guide KIT DSGKU: CE/MDD Class IIa, Dentis Co., Ltd

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-08800053081894 Basic UDI-DI 08800053081894UDI-DI	Date22 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number08800053081894 UDI-DI	Date3 Feb 2023Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI B-08800053081894 — open Devices and search for it
AccessGUDID record UDI-DI 08800053081894

Across registries

2 registries list this device

EUDAMED Basic UDI-DI B-08800053081894 registered 22 Sep 2026 Active
FDA GUDID UDI-DI 08800053081894 listed 3 Feb 2023 Listed

Timeline

2 dated events

3 Feb 2023 Listed FDA GUDID 08800053081894
22 Sep 2026 Registered EUDAMED B-08800053081894

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Simple Guide KIT
Generic name: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device name: Save Bone Trimming Kit
Model / reference: DSGKU, DBPK

Primary DI / UDI-DI: 08800053081894
Basic UDI-DI: B-08800053081894
FDA product code: NDP
EMDN code: P01020180 Dental implants - accessories
GMDN term: Dental/maxillofacial surgical procedure kit, non-medicated, 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: Spain
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device class	EUDAMED 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.