510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854882Substantially Equivalent

Protec/visible Light-Cured Sealant/dental Restorat

Lee Pharmaceuticals, South El Monte CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854882 is the FDA 510(k) clearance record for PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT, a class II device, cleared for Lee Pharmaceuticals on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 29 510(k) clearances for Lee Pharmaceuticals, from to . As of , FDA records show no recalls naming K854882.

Clearance record

Decision date
Received
(55 days to decision)
Product code
EBC Sealant, Pit And Fissure, And Conditioner
Regulation
21 CFR 872.3765
Device class
Class II
Review panel
Dental
Applicant
Lee Pharmaceuticals 1444 Santa Anita, South El Monte CA
Third party review
No

Clearances, product code EBC

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