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Non-Engaging CrCo abutment 25º RP

by Implant Protesis Dental 2004 S.L. 2 variants

Ref IPD/1A-BR-21Model CCR/CCA510(k) K251471

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251471↗

+4 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8435566607BY Basic UDI-DI 08435566627149UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK251471 Date20 Aug 2025IssuedStatusActive

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 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Straight Co-Cr castable abutment ; Angled Co-Cr castable abutment
Model / Reference
CCR/CCA, IPD/1A-BR-21
Primary DI / UDI-DI
08435566627149
Basic UDI-DI
8435566607BY
EMDN Code
Q01020602 Combined dental prostheses
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000002195
FDA applicant
Implant Protesis Dental 2004, S.L.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Non-Engaging CrCo abutment 25º RP is a castable cobalt-chromium (Co-Cr) abutment designed for dental implant applications. It is available in straight and angled configurations as specified in the device nomenclature.

This implantable device is non-sterile, intended for single use, and not reusable. It does not contain medicinal products, animal or human tissues, latex, or endocrine disruptors. The device is supplied with reference IPD/1A-BR-21 and model CCR/CCA, and complies with applicable legislation under MDR and FDA 510(k) authorization.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Non-Engaging CrCo abutment 25º RP sterile?

    No, the device is not sterile as indicated by the STERILE field being set to 0. It requires sterilization before use, as noted by the STERILIZATION field being set to 1.

  • Can the Non-Engaging CrCo abutment 25º RP be reused after initial use?

    No, the device is not reusable. The REUSABLE field is set to 0, and it is designated as a single-use implantable device.

  • What materials are used in the Non-Engaging CrCo abutment 25º RP?

    The abutment is made of cobalt-chromium (Co-Cr), as indicated by the device name 'Straight Co-Cr castable abutment ; Angled Co-Cr castable abutment' in the specifications and the trade name 'Non-Engaging CrCo abutment 25º RP', where CrCo refers to cobalt-chromium.

Properties

  • Implantable
  • Sutures
  • CMR Substance

Other properties (11)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No