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510(k) K820598

HOT & COLD PULP TESTER #4001 by Analytic Technology — Product Code EAT

K820598 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "HOT & COLD PULP TESTER #4001". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code EAT (Tester, Pulp), a Class II device regulated under 21 CFR 872.1720. Analytic Technology has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1982
Date Received
March 4, 1982
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 Analytic Technology

  • K921604 — TOUCH N' HEAT, MODIFICATION (August 24, 1992)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)
  • K890735 — COATED APEX PROBE (April 19, 1989)
  • K864500 — ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (March 19, 1987)
  • K832179 — HOT PROBE MODEL 6001 (October 4, 1983)
  • K823486 — TOUCH-N-HEAT MODEL 5001 (January 18, 1983)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)
  • K790799 — PULPTESTER MODEL 2001 (May 31, 1979)

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)
  • K960799 — ORTHO-ICE (May 9, 1996)
  • K950237 — DIGITEST (June 9, 1995)

FDA data resources