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Scan Body

by Biodenta Swiss AG 9 variants

Ref CAD-SBSBLNCModel CAD-SBBBLB0

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0764016973CADSBVV Basic UDI-DI 07640169735585UDI-DIDate21 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07640169735585 UDI-DI Date5 Jun 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Scan Body EUDAMED
Biodenta GUDID
Generic Name
Dental implant abutment analog, intraoral-scanning, single-use
Device Name
Cad-SBBBLB0
Model / Ref / Catalog
CAD-SBBBLB0, CAD-SBSBLNC
Primary DI / UDI-DI
07640169735585
Basic UDI-DI
0764016973CADSBVV
FDA Product Code
NDP
EMDN Code
Q010207 Dental impression devices for prosthetic dentistry
GMDN Term
Dental implant abutment analog, intraoral-scanning, single-use
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CH-MF-000034374
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Other devices from Biodenta Swiss AG

See all devices from Biodenta Swiss AG →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No