510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K120552Substantially Equivalent

Air Lift/xerostom Artificial Saliva

Biocosmetics Laboratories, Monroe CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K120552 is the FDA 510(k) clearance record for AIR LIFT/XEROSTOM ARTIFICIAL SALIVA, cleared for Biocosmetics Laboratories on under FDA product code LFD (Saliva, Artificial). FDA records list one 510(k) clearance for Biocosmetics Laboratories. As of , FDA records show no recalls naming K120552.

Clearance record

Decision date
Received
(104 days to decision)
Product code
LFD Saliva, Artificial
Device class
Unclassified
Review panel
Unknown
Applicant
Biocosmetics Laboratories 57 Lazy Brook Rd., Monroe CT
510(k) summary
Statement
Third party review
No

Clearances, product code LFD

Trailing 12 months
1 clearance under product code LFD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260