St Stcswl

by Shinhung MST Co., Ltd.

St Stcswl is a Class II device made by Shinhung MST Co., Ltd., cleared under FDA 510(k) K221752 on 4 Jun 2023 and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 08806343916631), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08806343916631 UDI-DI	Date9 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK221752	Date4 Jun 2023Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08806343916631
FDA 510(k) database 510(k) number K221752

Across registries

2 registries list this device

FDA 510(k) K221752 decided 4 Jun 2023 Active
FDA GUDID UDI-DI 08806343916631 listed 9 Jun 2023 Listed

Timeline

2 dated events

4 Jun 2023 Cleared FDA 510(k) K221752
9 Jun 2023 Listed FDA GUDID 08806343916631

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: St
Generic name: Dental implant suprastructure, temporary, preformed, single-use
Model / reference: STCSWL

Primary DI / UDI-DI: 08806343916631
510(k) Number: K221752
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

Similar devices in this category

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

Other devices from Shinhung MST Co., Ltd.

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8, all answered No)