Cleared Traditional

FLORIDA PROBE PERIODONTAL PROBE

K890493 · Florida Probe Corp. · Dental
Mar 1989
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K890493 is an FDA 510(k) clearance for the FLORIDA PROBE PERIODONTAL PROBE, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Florida Probe Corp. (Gainesville, US). The FDA issued a Cleared decision on March 13, 1989, 41 days after receiving the submission on January 31, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K890493 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1989
Decision Date March 13, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EIL — Gauge, Depth, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565