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Si NSHAN4546

by Shinhung MST Co., Ltd.

Si NSHAN4546 is a Class II device made by Shinhung MST Co., Ltd., cleared under FDA 510(k) K223395 on 3 Feb 2023 and listed in FDA GUDID since 16 Feb 2023 (UDI-DI 08806343918741), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K223395

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08806343918741 UDI-DI Date16 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK223395 Date3 Feb 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223395 decided 3 Feb 2023 Active
  • FDA GUDID UDI-DI 08806343918741 listed 16 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K223395
  2. Listed FDA GUDID 08806343918741

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Si
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / reference
NSHAN4546
Primary DI / UDI-DI
08806343918741
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Cleared under the same submission (K223395)

and 8 more cleared under K223395

Similar devices in this category

Other devices filed under Dental implant suprastructure, temporary, preformed, single-use.

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 (8, all answered No)