Cleared Traditional

MODEL 200A ELECTRONIC FORCE-SENSING PROBE

K884813 · Vine Valley Research · Dental
Jan 1989
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K884813 is an FDA 510(k) clearance for the MODEL 200A ELECTRONIC FORCE-SENSING PROBE, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Vine Valley Research (Middlesex, US). The FDA issued a Cleared decision on January 5, 1989, 49 days after receiving the submission on November 17, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K884813 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1988
Decision Date January 05, 1989
Days to Decision 49 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