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Interface Chrome Cobalt 6mm Index Immac 0606

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

Ref IMMAC 0606Model NON-STERILE COMPONENTS METALLIC ABUTMENT

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221453

FDA submission, from GUDID

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 07899995255716UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995255716 UDI-DI Date11 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221453 Date15 Dec 2022DecidedStatusActive

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  • Withdrawn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 FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Interface Crco Abut. Micro 6mm Inde EUDAMED
Interface Chrome Cobalt 6mm Index GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
ABUTMENT CHROME COBALT | INTERFACE CHROME COBALT | ABUTMENT CHROME COBALT (Prosthetic Intermediate) | INTERFACE CHROME COBALT (Prosthetic Intermediate)
Model / Ref / Catalog
IMMAC 0606, NON-STERILE COMPONENTS METALLIC ABUTMENT
Primary DI / UDI-DI
07899995255716
Basic UDI-DI
999520000008JW
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K221453)

Show all (12)

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No