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510(k) K915243

TOUCH 'N HEAT MODEL 5002, MODIFICATION by Analytic Technology — Product Code EKM

K915243 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "TOUCH 'N HEAT MODEL 5002, MODIFICATION". The FDA issued a decision of Substantially Equivalent on January 21, 1992. The device falls under product code EKM (Gutta-Percha), a Class I device regulated under 21 CFR 872.3850. Analytic Technology has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1992
Date Received
October 31, 1991
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

Other clearances by Analytic Technology

  • K921604 — TOUCH N' HEAT, MODIFICATION (August 24, 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)
  • 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)

Other clearances for product code EKM

  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070246 — DOWN PAK (February 16, 2007)
  • K051573 — TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (June 26, 2006)
  • K042870 — ENDO TWINN (January 11, 2005)
  • K023819 — FIBERFILL SGP (March 26, 2003)
  • K971641 — ANTIBACTERIAL GUTTA PERCHA (July 21, 1997)
  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K931742 — INJECT-R FILL (May 27, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K910224 — THERMAPREP (March 29, 1991)

FDA data resources