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Silatrix Oral Gel

by Sa3, LLC 2 variants

510(k) K202000

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202000 Date20 Nov 2020ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0856-2022 FDA Class II initiated 21 Feb 2022

    Due to failure of microbial testing for total aerobic microbial count (TAMC).

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLR
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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