Cleared Traditional

FORAMATRON APICAL FORAMEN LOCATOR

K811995 · Parker Laboratories, Inc. · Dental
Sep 1981
Decision
70d
Days
Risk

About This 510(k) Submission

K811995 is an FDA 510(k) clearance for the FORAMATRON APICAL FORAMEN LOCATOR, submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981, 70 days after receiving the submission on July 13, 1981. This device falls under the Dental review panel.

Submission Details

510(k) Number K811995 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1981
Decision Date September 21, 1981
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code
Device Class