DeviceClearance

Product code PME— Dental

CeraClean

Classification name
External Cleaning Solution
Device class
Class 2
Regulation
21 CFR 872.3260
Advisory panel
Dental
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PME under 21 CFR 872.3260, via openFDA

Market context for product code PME

FDA has cleared 3 devices under product code PME between 2015 and 2019, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PME

Recent clearances under product code PME

Data sourced from openFDA. This site is unofficial and independent of the FDA.