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Metallic Abutment CALE 00-2

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref CALE 00-2Model NON-STERILE COMPONENTS METALLIC ABUTMENT

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000008JW Basic UDI-DI 07899995268075UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995268075 UDI-DI Date30 Jun 2022ListedStatusListed 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 23 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  • Withdrawn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
Abut. Crco Abut. Conical Rot. C/ Prh 20 EUDAMED
Metallic Abutment GUDID
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Device Name
ABUTMENT CHROME COBALT | INTERFACE CHROME COBALT | ABUTMENT CHROME COBALT (Prosthetic Intermediate) | INTERFACE CHROME COBALT (Prosthetic Intermediate)
Model / Ref / Catalog
CALE 00-2, NON-STERILE COMPONENTS METALLIC ABUTMENT
Description
PLASTIC ABUTMENT CRCO CONICAL W/PRH 20
Primary DI / UDI-DI
07899995268075
Basic UDI-DI
999520000008JW
510(k) Number
FDA Product Code
NHA
EMDN Code
P01020101 Dental implants
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Portugal
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

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

Cleared under the same submission (K051859)

Show all (12)

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

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Properties

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

Other properties (18)

  • 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
  • Expiration Date: No