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BioHorizons PGSSB8

by Biohorizons Implant Systems Inc. EUDAMEDGUDID

Active European Union

Ref PGSSB8Model BioHorizons Dental Instruments

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08472360IINST016UT Basic UDI-DIDate17 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847236013561 UDI-DIDate24 Jan 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
BioHorizons
Generic Name
Dental implant abutment analog, intraoral-scanning, single-use
Device Name
Single-Use Scanning Devices
Model / Reference
PGSSB8, BioHorizons Dental Instruments
Primary DI / UDI-DI
00847236013561
Basic UDI-DI
08472360IINST016UT
FDA Product Code
NDP
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental implant abutment analog, intraoral-scanning, single-use
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Biohorizons Implant Systems Inc.

See all devices from Biohorizons Implant Systems Inc. →

Properties

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

Other properties (19)

  • 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