Cleared Traditional

K971898 - PERMALUTE, TRY-IN PASTE (FDA 510(k) Clearance)

K971898 · Ultradent Products, Inc. · Dental device

Jun 1997

Decision

33d

Days

Class 2

Risk

K971898 is an FDA 510(k) clearance for the PERMALUTE, TRY-IN PASTE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 24, 1997, 33 days after receiving the submission on May 22, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K971898 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 22, 1997
Decision Date	June 24, 1997
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement