Cleared Traditional

K971284 - OPALDAM
(FDA 510(k) Clearance)

K971284 · Ultradent Products, Inc. · Dental device

Jun 1997

Decision

57d

Days

Class 1

Risk

K971284 is an FDA 510(k) clearance for the OPALDAM. This device is classified as a Retractor, All Types (Class I - General Controls, product code EIG).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 3, 1997, 57 days after receiving the submission on April 7, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K971284 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 1997
Decision Date	June 03, 1997
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement