Clearance Summary
ENDODONTIC ELECTRONIC SPREADER HEATER received FDA 510(k) clearance under submission number K853183, sponsored by Sturgeon Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-10-16.
- Submission: K853183
- Applicant / Sponsor: Sturgeon Engineering Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1985-10-16
Classification & Regulation
This clearance is catalogued under FDA product code EKK and 21 CFR 872.4565, within the Dental review panel as a Class I device.