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510(k) K863133

PROPHY CARE PASTE by Imd, Inc. — Product Code EJR

K863133 is an FDA 510(k) premarket notification submitted by Imd, Inc. for the device "PROPHY CARE PASTE". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Imd, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
August 15, 1986
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 Imd, Inc.

  • K113662 — FENESTRATED NERVE BLOCK NEEDLE (April 20, 2012)
  • K865082 — PROPHY CARE SOLUTION (February 12, 1987)
  • K864215 — PROPHY CARE SOLUTION (November 18, 1986)

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