Cleared Traditional

K943373 - PERMAGEN F/DC (FDA 510(k) Clearance)

K943373 · Ultradent Products, Inc. · Dental device

Aug 1994

Decision

41d

Days

Class 2

Risk

K943373 is an FDA 510(k) clearance for the PERMAGEN F/DC. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 23, 1994, 41 days after receiving the submission on July 13, 1994.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K943373 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1994
Decision Date	August 23, 1994
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement