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Cemented Abutment

by Dentis Co., Ltd 64 variants

Ref DECAR548HS

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-08806169164872 Basic UDI-DI 08806169164872UDI-DIDate8 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
DECAR548HS
Primary DI / UDI-DI
08806169164872
Basic UDI-DI
B-08806169164872
EMDN code
P01020180 Dental implants - accessories
Device class
Class IIb
EU registration type
Legacy device (under a directive)
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

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: 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