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Healing Abutment CI 3406

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

Part of a family of 138 devices: see the family page

Ref CI 3406Model STERILE COMPONENTS

Healing Abutment CI 3406 is a device classified as Class IIa in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 999520000057KB), cleared under FDA 510(k) K051859 on 23 Sep 2005 and listed in FDA GUDID since 9 Feb 2021 (UDI-DI 07899995205575), active as of 25 Oct 2026.

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051859

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000057KB Basic UDI-DI 07899995205575UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995205575 UDI-DI Date9 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051859 Date23 Sep 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000057KB registered 27 May 2026 Active
  • FDA 510(k) K051859 decided 23 Sep 2005 Active
  • FDA GUDID UDI-DI 07899995205575 listed 9 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051859
  2. Listed FDA GUDID 07899995205575
  3. Registered EUDAMED 999520000057KB

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  • Withdrawn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
Healing Cap He Ø3.4XØ3.8X6MM EUDAMED
Healing Abutment GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Healing Cap
Model / Ref / Catalog
CI 3406, STERILE COMPONENTS
Primary DI / UDI-DI
07899995205575
Basic UDI-DI
999520000057KB
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Cleared under the same submission (K051859)

and 8 more cleared under K051859

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)