Spreader, Pulp Canal Filling Material, Endodontic
The Endodontic Pulp Canal Filling Material Spreader is a tapered, pointed dental instrument used during root canal obturation to laterally condense gutta-percha points within the canal, allowing additional accessory points to be placed and ensuring a dense, void-free fill. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKK, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKK
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853183 | ENDODONTIC ELECTRONIC SPREADER HEATER | Oct 16, 1985 | Substantially Equivalent | Sturgeon Engineering Co. |
FEI Numbers
This FDA classification entry is associated with 86 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 86 registration numbers. Click on an entry to view related FDA registrations.