510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PMEClass II

External Cleaning Solution

21 CFR 872.3260 / Dental
FDA source (opens on fda.gov)

PME is the FDA product code for External Cleaning Solution, a class II device type, regulated under 21 CFR 872.3260. FDA's definition for this code reads: "For use on dental restorations, external to the mouth, prior to insertion into the mouth". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PME
Device name
External Cleaning Solution
FDA definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code PME

By decision year
3 clearances under product code PME with a decision year between 2015 and 2019, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PME by decision year
YearClearances
20151
20171
20191

Applicants with the most clearances

Product code PME
Applicants holding the most 510(k) clearances under product code PME
ApplicantClearances
Bisco Inc1
Denali Corporation1
Kuraray Noritake Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order