Solution, Cement Dissolving

FDA product code KZP · Class II (moderate risk) · 21 CFR 872.3750 · Dental

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K920843Tooth ConditionerKZP · Traditional Confi-Dental Products Co.04/08/1993SE
K771974Solvenex I-0KZP · Traditional Den-Mat Corp.01/12/1978SE

Recalls

RecallProductFirmInitiated
Z-1133-2014 Class IIBencoDental tartar & stain remover ultrasonic cleaning solution Product Usage:…As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling… Heraeus Kulzer, LLC.02/10/2014Terminated