Cleared Traditional

PROVIT

K800060 · Parker Laboratories, Inc. · Dental
Jan 1980
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K800060 is an FDA 510(k) clearance for the PROVIT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980, 13 days after receiving the submission on January 10, 1980. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K800060 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1980
Decision Date January 23, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275