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U.S. Department of Health and Human Services

Product Classification

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Device external cleaning solution
Definition For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Physical State Solution consists of a gel or liquid that is applied directly to the dental restoration.
Technical Method Applied manually by applicator to the dental restoration, then rinsed thoroughly with water and air dried before placement in the mouth.
Target Area The target area of the body is a tooth which will have the dental restoration applied to it.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePME
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(K) Exempt
Regulation Number 872.3260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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