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s-Clean Plastic coping

by Dentis Co., Ltd 5 variants

Ref DSHP55HModel DENTIS Implant Surgical Instrument System

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88061691DENTIS-I7L Basic UDI-DI 08800053040228UDI-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  • Withdrawn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, DSHP55H
Primary DI / UDI-DI
08800053040228
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)

  • Supplied sterile: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No