PME · Class II · 21 CFR 872.3260

FDA Product Code PME: External Cleaning Solution

For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth.

Leading manufacturers include Bisco, Inc. and Kuraray Noritake Dental, Inc..

3
Total
3
Cleared
145d
Avg days
2015
Since

FDA 510(k) Cleared External Cleaning Solution Devices (Product Code PME)

3 devices
1–3 of 3
Cleared Oct 08, 2019
KATANA Cleaner, KATANA Cleaner (Trial)
K191133
Kuraray Noritake Dental, Inc.
Dental · 162d
Cleared Apr 14, 2017
CeraClean
K163171
Bisco, Inc.
Dental · 151d

About Product Code PME - Regulatory Context