510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K062502Substantially Equivalent

Osspray Cleaning Compound

Ospray, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062502 is the FDA 510(k) clearance record for OSSPRAY CLEANING COMPOUND, a class I device, cleared for Ospray, Ltd. on under FDA product code EJR (Agent, Polishing, Abrasive, Oral Cavity). FDA records list one 510(k) clearance for Ospray, Ltd. As of , FDA records show no recalls naming K062502.

Clearance record

Decision date
Received
(112 days to decision)
Product code
EJR Agent, Polishing, Abrasive, Oral Cavity
Regulation
21 CFR 872.6030
Device class
Class I
Review panel
Dental
Applicant
Ospray, Ltd. 700 Thirteenth St. N.W, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJR

Trailing 12 months

FDA records hold no clearances under product code EJR in the trailing twelve months.

FDA records show no clearances under product code EJR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260