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Implant Mount

by B.T.I. Biotechnology Institute, S.l 7 variants

Ref PCG325

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 linked in EUDAMED

A group certificate may exist

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 Number84353898IMP-MOUNTX2 Basic UDI-DI 08435389826880UDI-DIDate21 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08435389826880 UDI-DI Date14 Apr 2025ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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
Stop & Guide Implant Mount; Interna Implant; 3.0 Platform; Ø2.5
Generic Name
Dental implant holding endpiece, reusable
Device Name
Implant Mount
Model / Reference
PCG325
Primary DI / UDI-DI
08435389826880
Basic UDI-DI
84353898IMP-MOUNTX2
Direct Marketing DI
08435389826880
FDA Product Code
NDP
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental implant holding endpiece, reusable
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
ES-MF-000001701

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Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: 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