Clearance Summary
IVORY PREMIUM RUBBER DAM received FDA 510(k) clearance under submission number K863816, sponsored by Columbus Dental Mfg. 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 1986-10-27.
- Submission: K863816
- Applicant / Sponsor: Columbus Dental Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6300
- Decision date: 1986-10-27
Classification & Regulation
This clearance is catalogued under FDA product code EIE and 21 CFR 872.6300, within the Dental review panel as a Class I device.