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510(k) K801974

ANALYTIC TECH. METAL POINT HEATER #3001 by Analytic Technology — Product Code ELA

K801974 is an FDA 510(k) premarket notification submitted by Analytic Technology for the device "ANALYTIC TECH. METAL POINT HEATER #3001". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code ELA (Instrument, Hand, Calculus Removal), a Class I device regulated under 21 CFR 872.4565. Analytic Technology has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hand, Calculus Removal
Device Class
Class I
Regulation Number
872.4565
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)
  • K820598 — HOT & COLD PULP TESTER #4001 (March 19, 1982)
  • K790799 — PULPTESTER MODEL 2001 (May 31, 1979)

Other clearances for product code ELA

  • K952363 — OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (August 15, 1995)
  • K854168 — TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (March 13, 1986)
  • K823326 — DENTAL INSTRUMENTS - CUTTING INSTRUMENT (November 24, 1982)

FDA data resources