Product code EKK
- Device name
- Spreader, Pulp Canal Filling Material, Endodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853183 | ENDODONTIC ELECTRONIC SPREADER HEATER | Sturgeon Engineering Co. | 1985-10-16 |
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