Cleared Traditional

K933612 - JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)
(FDA 510(k) Clearance)

K933612 · Jedental Co., Inc. · Dental device

Feb 1994

Decision

220d

Days

Class 2

Risk

K933612 is an FDA 510(k) clearance for the JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT). This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Jedental Co., Inc. (Southampton, US). The FDA issued a Cleared decision on February 24, 1994, 220 days after receiving the submission on July 19, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K933612 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 19, 1993
Decision Date	February 24, 1994
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement