Cleared Traditional

K931870 - BONDING RESIN PRODUCT LINE (FDA 510(k) Clearance)

K931870 · Ultradent Products, Inc. · Dental device

Jul 1993

Decision

99d

Days

Class 2

Risk

K931870 is an FDA 510(k) clearance for the BONDING RESIN PRODUCT LINE. 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 July 22, 1993, 99 days after receiving the submission on April 14, 1993.

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

Submission Details

510(k) Number	K931870 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 14, 1993
Decision Date	July 22, 1993
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement