Cleared Traditional

K800060 - PROVIT (FDA 510(k) Clearance)

K800060 · Parker Laboratories, Inc. · Dental device

Jan 1980

Decision

13d

Days

Class 2

Risk

K800060 is an FDA 510(k) clearance for the PROVIT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

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