Point, Silver, Endodontic
The Endodontic Silver Point is a thin, tapered rod made of silver used as a root canal filling material to obturate the prepared root canal space, historically employed for its antimicrobial properties, though largely replaced by modern gutta-percha techniques. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKL, regulated under 21 CFR 872.3840 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKL
- Device Class
- FDA class 1
- Regulation Number
- 872.3840
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992582 | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | Oct 21, 1999 | Substantially Equivalent | Pacific Implant, Inc. |
| K961089 | PULPDENT ENDOPREP II | Apr 23, 1996 | Substantially Equivalent | Pulpdent Corp. |
| K822568 | EAR PROBES | Sep 14, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.