Cleared Traditional

K912497 - IONOBOND (FDA 510(k) Clearance)

K912497 · Voco GmbH · Dental device

Jul 1991

Decision

55d

Days

Class 2

Risk

K912497 is an FDA 510(k) clearance for the IONOBOND. 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 July 30, 1991, 55 days after receiving the submission on June 5, 1991.

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

Submission Details

510(k) Number	K912497 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 05, 1991
Decision Date	July 30, 1991
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement