Product Code: EKQ FDA class 1 21 CFR 872.4565

Preparer, Root Canal Endodontic

Dental

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.

510(k)s
2
FEI Numbers
50
Registration Numbers
50
Unique Applicants
2
Years Active
3

Research product code EKQ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

Loading...

Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K832378 VIBRATORY ENDODONTIC SYSTEM
K801463 OJ-1 ENDODONIC ROOT CANAL FILE HOLDER

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.