Sa3, LLC
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Silatrix Oral Gel Ref K252425
Regimes: 510(k) Registry: 510(k)Silatrix Oral Gel Ref K202000
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 21 Feb 2022 Z-0856-2022 Class II Terminated Due to failure of microbial testing for total aerobic microbial count (TAMC).
Frequently asked questions
How many devices does Sa3, LLC have in the registry?
The registry currently lists 2 devices for Sa3, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sa3, LLC's devices?
Among its 2 most recently registered devices, Sa3, LLC has devices listed in FDA 510(k) (2 devices).
Are there FDA recall records for Sa3, LLC?
FDA recall records list 1 recall initiated by Sa3, LLC, the most recent initiated on 21 Feb 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sa3, LLC in the registry?
The most recently registered devices listed for Sa3, LLC include Silatrix Oral Gel.