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510(k) K960799

ORTHO-ICE by Ultimate Wireforms, Inc. — Product Code EAT

K960799 is an FDA 510(k) premarket notification submitted by Ultimate Wireforms, Inc. for the device "ORTHO-ICE". The FDA issued a decision of Substantially Equivalent on May 9, 1996. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Ultimate Wireforms, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1996
Date Received
February 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pulp
Device Class
Class II
Regulation Number
872.1720
Review Panel
DE
Submission Type

Other clearances by Ultimate Wireforms, Inc.

  • K923837 — DIMPLED MULTI MODULUS ARCH WIRE (March 31, 1993)
  • K924805 — ORTHODONTIC ARCH WIRE (March 31, 1993)
  • K923836 — .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING (December 23, 1992)
  • K923838 — THE ULTIMATE RCS ARCH WIRE (December 4, 1992)
  • K923839 — NITINOL GENTLE TOUCH COIL SPRING (October 15, 1992)

Other clearances for product code EAT

  • K022097 — THERMIQUE (September 6, 2002)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)
  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K011666 — CHILLIT (August 6, 2001)
  • K990225 — ENDO ANALYZER, MODEL 8005, MODIFIED (February 25, 1999)
  • K973439 — ENDO ANALYZER, MODEL 8005 (December 8, 1997)
  • K970715 — SYSTEM B HEAT SOURCE (April 7, 1997)
  • K963862 — TOUCH N' HEAT (December 2, 1996)
  • K950237 — DIGITEST (June 9, 1995)
  • K950238 — GENTAL PULSE (May 9, 1995)

FDA data resources