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Si SIDAN5054H

by Shinhung MST Co., Ltd.

Ref SIDAN5054H

Si SIDAN5054H is a device classified as Class IIb in the EU and Class II in the US made by Shinhung MST Co., Ltd., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-08809458310707), cleared under FDA 510(k) K223395 on 3 Feb 2023 and listed in FDA GUDID since 16 Feb 2023 (UDI-DI 08809458310707), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223395

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809458310707 Basic UDI-DI 08809458310707UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809458310707 UDI-DI Date16 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223395 Date3 Feb 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809458310707 registered 26 Oct 2026 Active
  • FDA 510(k) K223395 decided 3 Feb 2023 Active
  • FDA GUDID UDI-DI 08809458310707 listed 16 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223395
  2. Listed FDA GUDID 08809458310707
  3. Registered EUDAMED B-08809458310707

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Luna EUDAMED
Si GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Sterile & non-sterile dental implant system
Model / reference
SIDAN5054H
Primary DI / UDI-DI
08809458310707
Basic UDI-DI
B-08809458310707
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
Legacy device (under a directive)
EU market of registration
Türkiye
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

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 (K223395)

and 8 more cleared under K223395

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Shinhung MST Co., Ltd.

  • Sola

    Class IIb

  • Sis

    Class IIa

  • Luna

    Class IIb

  • Sola

    Class IIb

See all devices from Shinhung MST Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)