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Conic Abutment AC 3604

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

Ref AC 3604Model STERILE COMPONENTS ABUTMENT

Conic Abutment AC 3604 is a device classified as Class IIb in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 999520000005JQ), cleared under FDA 510(k) K170398 on 21 Nov 2017 and listed in FDA GUDID since 15 Feb 2021 (UDI-DI 07899995200679), 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) K170398

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 Number999520000005JQ Basic UDI-DI 07899995200679UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995200679 UDI-DI Date15 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170398 Date21 Nov 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000005JQ registered 18 Aug 2026 Active
  • FDA 510(k) K170398 decided 21 Nov 2017 Active
  • FDA GUDID UDI-DI 07899995200679 listed 15 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170398
  2. Listed FDA GUDID 07899995200679
  3. Registered EUDAMED 999520000005JQ

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  • Withdrawn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
Abut. Conical He Ø3.6x4mm EUDAMED
Conic Abutment GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
AC 3604, STERILE COMPONENTS ABUTMENT
Primary DI / UDI-DI
07899995200679
Basic UDI-DI
999520000005JQ
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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, permanent, preformed

Cleared under the same submission (K170398)

and 8 more cleared under K170398

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
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)