Cleared Traditional

K922854 - AQUA MERON (FDA 510(k) Clearance)

K922854 · Voco GmbH · Dental device

Aug 1992

Decision

51d

Days

Class 2

Risk

K922854 is an FDA 510(k) clearance for the AQUA MERON. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on August 5, 1992, 51 days after receiving the submission on June 15, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K922854 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 15, 1992
Decision Date	August 05, 1992
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement