Broach, Endodontic
The Endodontic Broach is a barbed or smooth wire instrument inserted into the root canal to engage and remove the dental pulp, cotton pellets, or paper points from within the canal space during endodontic treatment procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKW, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKW
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K871493 | DENTI-TRAY(TM) | Jun 24, 1987 | Substantially Equivalent | Advanced Medical, Inc. |
| K870765 | CANNULATED INSTRUMENT CLEANERS | May 27, 1987 | Substantially Equivalent | Treace Medical, Inc. |
| K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Aug 01, 1986 | Substantially Equivalent | Walter Lorenz Surgical, Inc. |
| K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Jul 12, 1983 | Substantially Equivalent | Union Branch |
| K823489 | ENDODONTIC BROACH-BARBED BROACH | Dec 15, 1982 | Substantially Equivalent | Union Broach, Div. Moyco Industries, Inc. |
| K800292 | ENDEX BROACH, ENDODONTIC | Feb 19, 1980 | Substantially Equivalent | Ipco Corp. |
| K760985 | HAND INSTRUMENTS | Nov 15, 1976 | Substantially Equivalent | Adp Intl., Inc. |
FEI Numbers
This FDA classification entry is associated with 40 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 40 registration numbers. Click on an entry to view related FDA registrations.