Home / 510(k) Clearances / K901973

510(k) K901973

CP-3 DENTAL POLISHING MATERIAL by Gresco Products, Inc. — Product Code EJR

K901973 is an FDA 510(k) premarket notification submitted by Gresco Products, Inc. for the device "CP-3 DENTAL POLISHING MATERIAL". The FDA issued a decision of Substantially Equivalent on June 1, 1990. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Gresco Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1990
Date Received
May 1, 1990
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 by Gresco Products, Inc.

  • K981524 — PRILANE (July 10, 1998)
  • K913405 — KAR-D-TEK (October 28, 1991)
  • K910813 — MET-ETCH (May 7, 1991)
  • K910803 — ENAMEL ETCHING GEL (March 15, 1991)
  • K854495 — GRESCO N.P. DENTAL ALLOY (December 27, 1985)
  • K854494 — CERAM-ETCH (December 23, 1985)

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)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)

FDA data resources