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i-Clean Shoulder Analog

by Dentis Co., Ltd

Ref DIISAWModel DENTIS Implant Surgical Instrument System

i-Clean Shoulder Analog (DIISAW) is a Class I device made by Dentis Co., Ltd., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 88061691DENTIS-I7L), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88061691DENTIS-I7L Basic UDI-DI 08800053040020UDI-DIDate27 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
DENTIS Implant Surgical Instrument System
Model / reference
DENTIS Implant Surgical Instrument System, DIISAW
Primary DI / UDI-DI
08800053040020
Basic UDI-DI
88061691DENTIS-I7L
EMDN code
P01020180 Dental implants - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000012523
Authorised representative
BEST FIT IMPLANTS S.A. ES-AR-000048728

Other devices from Dentis Co., Ltd.

See all devices from Dentis Co., Ltd. →

Properties

  • Sterilise before use
Other properties (13, all answered No)