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Sa3, LLC

Los Angeles, CA, US

Sa3, LLC appears in FDA device records in Los Angeles, CA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Sa3, LLC between 2020 and 2025. The busiest year on record is 2020, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sa3, LLC, by decision year
YearClearances
20201
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252425Silatrix Oral GelOLRSubstantially Equivalent
K202000Silatrix Oral GelOLRSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

This record is listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0856-2022Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gmDue to failure of microbial testing for total aerobic microbial count (TAMC).Class IITerminated

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain