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PME — External Cleaning Solution Class II

FDA Device Classification

Classification Details

Product Code
PME
Device Class
Class II
Regulation Number
872.3260
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191133kuraray noritake dentalKATANA Cleaner, KATANA Cleaner (Trial)October 8, 2019
K163171biscoCeraCleanApril 14, 2017
K152322denali corporationResolve 2.0December 16, 2015