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510(k) K832179

HOT PROBE MODEL 6001 by Analytic Technology — Product Code EEG

K832179 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "HOT PROBE MODEL 6001". The FDA issued a decision of Substantially Equivalent on October 4, 1983. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. Analytic Technology has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1983
Date Received
July 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat Source For Bleaching Teeth
Device Class
Class I
Regulation Number
872.6475
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)
  • 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 EEG

  • K122725 — TANDA PEARL, ULTRAWYTE, PEARL (November 27, 2012)
  • K110888 — ABSOLUTE WHITE LIGHT (January 12, 2012)
  • K063704 — BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (February 20, 2007)
  • K052040 — QUICKSMILE (October 18, 2005)
  • K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (November 8, 2004)
  • K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (November 8, 2004)
  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)

FDA data resources