External Cleaning Solution

FDA product code PME · Class II (moderate risk) · 21 CFR 872.3260 · Dental

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K191133KATANA Cleaner, KATANA Cleaner (Trial)PME · Traditional Kuraray Noritake Dental, Inc.10/08/2019SE
K163171CeraCleanPME · Traditional Bisco, Inc.04/14/2017SE
K152322Resolve 2.0PME · Traditional Denali Corporation12/16/2015SE