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Vioseal X-a0.5

by Spident Co., Ltd.

Vioseal X-a0.5 is a Class II device made by Spident Co., Ltd., cleared under FDA 510(k) K262050 on 11 Sep 2026 and listed in FDA GUDID since 17 Sep 2026 (UDI-DI 08809262950939), 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) K262050

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 Number08809262950939 UDI-DI Date17 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK262050 Date11 Sep 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K262050 decided 11 Sep 2026 Active
  • FDA GUDID UDI-DI 08809262950939 listed 17 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K262050
  2. Listed FDA GUDID 08809262950939

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vioseal X
Generic name
Hygroscopic dental cement
Model / reference
Vioseal X-a0.5
Primary DI / UDI-DI
08809262950939
510(k) Number
FDA product code
KIF
GMDN term
Hygroscopic dental cement
Device class
Class II
Regulation number
872.3820
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K262050)

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)