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510(k) K823486

TOUCH-N-HEAT MODEL 5001 by Analytic Technology — Product Code EKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1983
Date Received
November 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gutta-Percha
Device Class
Class I
Regulation Number
872.3850
Review Panel
DE
Submission Type

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  • K864500 — ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (March 19, 1987)
  • K832179 — HOT PROBE MODEL 6001 (October 4, 1983)
  • K820598 — HOT & COLD PULP TESTER #4001 (March 19, 1982)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)
  • K790799 — PULPTESTER MODEL 2001 (May 31, 1979)

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  • K931742 — INJECT-R FILL (May 27, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K915243 — TOUCH 'N HEAT MODEL 5002, MODIFICATION (January 21, 1992)