Home / 510(k) Clearances / K024343

510(k) K024343

BUTLER GUM PROPHY PASTE WITH NOVAMIN by Usbiomaterials Corp. — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2003
Date Received
December 27, 2002
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 Usbiomaterials Corp.

  • K000149 — NOVABONE-BIOGLASS BONE GRAFT PARTICULATE (February 7, 2000)
  • K992416 — PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE (October 15, 1999)
  • K962494 — PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE (September 20, 1996)
  • K930115 — PERIOGLASS (November 4, 1993)

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)