510(k) K081273

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 10, 2008

Date Received

May 5, 2008

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Dental Amalgam

Device Class

Class II

Regulation Number

872.3070

Review Panel

DE

Submission Type

Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth