Cleared Traditional

K920060 - DENTAL SOLDER ALLOY (FDA 510(k) Clearance)

K920060 · Deringer-Ney, Inc. · Dental device

Apr 1992

Decision

87d

Days

Class 2

Risk

K920060 is an FDA 510(k) clearance for the DENTAL SOLDER ALLOY. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on April 2, 1992, 87 days after receiving the submission on January 6, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number	K920060 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 06, 1992
Decision Date	April 02, 1992
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement