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Ipd Prem

by Implant Protesis Dental 2004 Sl 32 variants

Ref IPD/DE-XN-00Model PREM

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8435566623BW Basic UDI-DI 08435566642043UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435566642043 UDI-DI Date30 Jan 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
IPDmilled NT - GH 0.5mm / Ti Blank Ø 12 mm EUDAMED
Ipd GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Device Name
IPDmilled Blanks
Model / Ref / Catalog
PREM, IPD/DE-XN-00
Primary DI / UDI-DI
08435566642043
Basic UDI-DI
8435566623BW
510(k) Number
FDA Product Code
NHA, PNP
EMDN Code
Q01020602 Combined dental prostheses
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K253253)

Show all (12)

Other devices from Implant Protesis Dental 2004 Sl

  • Ipd Prem

    Class II

  • Ipd Prem

    Class II

  • Ipd Prem

    Class II

  • Ipd Prem

    Class II

  • Ipd Prem

    Class II

  • Ipd Prem

    Class II

See all devices from Implant Protesis Dental 2004 Sl →

Properties

  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No