External Cleaning Solution
The External Cleaning Solution (product code PME) is a Class 2 dental device intended for use on dental restorations external to the mouth prior to insertion into the oral cavity, regulated under 872.3260. It requires 510(k) clearance and falls within the dental medical specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PME
- Device Class
- FDA class 2
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
Definition
For use on dental restorations, external to the mouth, prior to insertion into the mouth.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Oct 08, 2019 | Substantially Equivalent | Kuraray Noritake Dental, Inc. |
| K163171 | CeraClean | Apr 14, 2017 | Substantially Equivalent | Bisco, Inc. |
| K152322 | Resolve 2.0 | Dec 16, 2015 | Substantially Equivalent | Denali Corporation |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.