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510(k) K890493

FLORIDA PROBE PERIODONTAL PROBE by Florida Probe Corp. — Product Code EIL

K890493 is an FDA 510(k) premarket notification submitted by Florida Probe Corp. for the device "FLORIDA PROBE PERIODONTAL PROBE". The FDA issued a decision of Substantially Equivalent on March 13, 1989. The device falls under product code EIL (Gauge, Depth, Instrument, Dental), a Class I device regulated under 21 CFR 872.4565. Florida Probe Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1989
Date Received
January 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Depth, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Florida Probe Corp.

  • K875076 — FLORIDA PROBE (March 10, 1988)

Other clearances for product code EIL

  • K911643 — ABIODENT PERIOTEMP(R) SYSTEM (July 9, 1991)
  • K885075 — ABIOMED PERIOTEMP(TM) PROBE (February 13, 1989)
  • K884813 — MODEL 200A ELECTRONIC FORCE-SENSING PROBE (January 5, 1989)
  • K880209 — PERIODONTAL PROBE - AUTOPROBE (April 27, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K872215 — PERIO-TEST (July 10, 1987)
  • K822793 — PIO ROOT CANAL INDICATOR (October 22, 1982)

FDA data resources