Cleared Traditional

K840297 - COLTENE ORALLOY MAGICAPS (FDA 510(k) Clearance)

K840297 · Coltene, Inc. · Dental device

Mar 1984

Decision

52d

Days

Class 2

Risk

K840297 is an FDA 510(k) clearance for the COLTENE ORALLOY MAGICAPS. This device is classified as a Alloy, Amalgam (Class II - Special Controls, product code EJJ).

Submitted by Coltene, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984, 52 days after receiving the submission on January 24, 1984.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.

Submission Details

510(k) Number	K840297 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 24, 1984
Decision Date	March 16, 1984
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—