EKK — Spreader, Pulp Canal Filling Material, Endodontic Class I
FDA product code EKK covers "Spreader, Pulp Canal Filling Material, Endodontic", a Class I medical device regulated under 21 CFR 872.4565. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- EKK
- Device Class
- Class I
- Regulation Number
- 872.4565
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K853183 | sturgeon engineering | ENDODONTIC ELECTRONIC SPREADER HEATER | October 16, 1985 |