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Si SAA4515R20HF

by Shinhung MST Co., Ltd.

Ref SAA4515R20HF

Si SAA4515R20HF 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-08809458319854), cleared under FDA 510(k) K160106 on 26 Aug 2016 and listed in FDA GUDID since 10 Oct 2016 (UDI-DI 08809458319854), 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) K160106

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-08809458319854 Basic UDI-DI 08809458319854UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809458319854 UDI-DI Date10 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK160106 Date26 Aug 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809458319854 registered 21 May 2026 Active
  • FDA 510(k) K160106 decided 26 Aug 2016 Active
  • FDA GUDID UDI-DI 08809458319854 listed 10 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160106
  2. Listed FDA GUDID 08809458319854
  3. Registered EUDAMED B-08809458319854

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  • Withdrawn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
SAA4515R20HF
Primary DI / UDI-DI
08809458319854
Basic UDI-DI
B-08809458319854
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
Size
Height — 8 Millimeter
Outer Diameter — 4.6 Millimeter
Length — 12.5 Millimeter

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 (K160106)

and 8 more cleared under K160106

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)