Cleared Traditional

K821783 - BEACH SILICATE FILLING & LINING APPLIC.
(FDA 510(k) Clearance)

Jul 1982
Decision
19d
Days
Risk

K821783 is an FDA 510(k) clearance for the BEACH SILICATE FILLING & LINING APPLIC...

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982, 19 days after receiving the submission on June 17, 1982.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K821783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date July 06, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code
Device Class