Preparer, Root Canal Endodontic
The Endodontic Root Canal Preparer is an instrument or system used to mechanically prepare and shape the root canal space to a consistent taper and size, facilitating effective irrigation, disinfection, and subsequent obturation during root canal treatment. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKQ, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKQ
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 50 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 50 registration numbers. Click on an entry to view related FDA registrations.