Home / 510(k) Clearances / K062502

510(k) K062502

OSSPRAY CLEANING COMPOUND by Ospray, Ltd. — Product Code EJR

K062502 is an FDA 510(k) premarket notification submitted by Ospray, Ltd. for the device "OSSPRAY CLEANING COMPOUND". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2006
Date Received
August 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

Other clearances for product code EJR

  • K171189 — AIR-FLOW PLUS Prophylaxis powder (September 11, 2017)
  • K131760 — WHIP MIX PREPPIES PLUS (March 26, 2014)
  • K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (August 6, 2012)
  • K103114 — OSSPRAY SYLC CR (March 14, 2011)
  • K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE (February 3, 2011)
  • K101104 — REMIN PRO (October 21, 2010)
  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)
  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K042048 — GELATO PROPHYLAXIS PASTE (October 26, 2004)

FDA data resources