Cleared Traditional

K950860 - PERMALUTE (FDA 510(k) Clearance)

K950860 · Ultradent Products, Inc. · Dental device

Mar 1995

Decision

24d

Days

Class 2

Risk

K950860 is an FDA 510(k) clearance for the PERMALUTE. 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 March 23, 1995, 24 days after receiving the submission on February 27, 1995.

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

Submission Details

510(k) Number	K950860 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 27, 1995
Decision Date	March 23, 1995
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF