510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905582Substantially Equivalent

Potassium Nitrate Composite Restoration Pit and

Milton Hodosh, M.D., Providence RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905582 is the FDA 510(k) clearance record for POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND, a class II device, cleared for Milton Hodosh, M.D. on under FDA product code EBC (Sealant, Pit And Fissure, And Conditioner). FDA records list 7 510(k) clearances for Milton Hodosh, M.D., from to . As of , FDA records show no recalls naming K905582.

Clearance record

Decision date
Received
(138 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
Milton Hodosh, M.D. 243 Elwood Ave., Providence RI
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