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St STR3508LS

by Shinhung MST Co., Ltd.

Ref STR3508LS

St STR3508LS 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 21 May 2026 (Basic UDI-DI B-08809457204489), cleared under FDA 510(k) K221752 on 4 Jun 2023 and listed in FDA GUDID since 8 Jun 2023 (UDI-DI 08809457204489), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221752

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/MDD EUDAMED NumberB-08809457204489 Basic UDI-DI 08809457204489UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809457204489 UDI-DI Date8 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK221752 Date4 Jun 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809457204489 registered 21 May 2026 Active
  • FDA 510(k) K221752 decided 4 Jun 2023 Active
  • FDA GUDID UDI-DI 08809457204489 listed 8 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K221752
  2. Listed FDA GUDID 08809457204489
  3. Registered EUDAMED B-08809457204489

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  • Withdrawn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
Stella EUDAMED
St GUDID
Generic name
Screw endosteal dental implant, two-piece
Device name
Sterile dental implant system
Model / reference
STR3508LS
Primary DI / UDI-DI
08809457204489
Basic UDI-DI
B-08809457204489
510(k) Number
FDA product code
DZE, NHA
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, two-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640, 872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
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: Screw endosteal dental implant, two-piece

Cleared under the same submission (K221752)

and 8 more cleared under K221752

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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)