Reamer, Pulp Canal, Endodontic
The Endodontic Pulp Canal Reamer is a hand or rotary instrument with a twisted, tapered shaft used to enlarge, shape, and clean the root canal by removing dentin and debris from the canal walls in preparation for obturation. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKP, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKP
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823686 | REAMER TYPE K ENDODONTIC | Dec 28, 1982 | Substantially Equivalent | United Dental Mfg., Inc. |
| K822620 | ROOT CANAL REAMERS, TYPE K | Sep 28, 1982 | Substantially Equivalent | Union Broach, Div. Moyco Industries, Inc. |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Feb 19, 1980 | Substantially Equivalent | Ipco Corp. |
| K770331 | DIALYSIS, JET SYSTEM | Apr 20, 1977 | Substantially Equivalent | Janneck Ent. of Texas |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Apr 05, 1977 | Substantially Equivalent | Ransom and Randolph |
| K770367 | ROOT CANAL FILES & REAMERS | Mar 01, 1977 | Substantially Equivalent | Cemco Tool Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.