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Healing Abutment CIHE 3602

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

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

Ref CIHE 3602Model STERILE COMPONENTS

Healing Abutment CIHE 3602 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) K193096 on 14 May 2020 and listed in FDA GUDID since 9 Feb 2021 (UDI-DI 07899995272461), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K193096

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000057KB Basic UDI-DI 07899995272461UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995272461 UDI-DI Date9 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK193096 Date14 May 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000057KB registered 27 May 2026 Active
  • FDA 510(k) K193096 decided 14 May 2020 Active
  • FDA GUDID UDI-DI 07899995272461 listed 9 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K193096
  2. Listed FDA GUDID 07899995272461
  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  • Withdrawn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 Ø3.6XØ4.0X2MM EUDAMED
Healing Abutment GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Healing Cap
Model / Ref / Catalog
CIHE 3602, STERILE COMPONENTS
Primary DI / UDI-DI
07899995272461
Basic UDI-DI
999520000057KB
510(k) Number
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
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
Portugal
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 (K193096)

and 8 more cleared under K193096

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

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)