Clearance Summary
PROPHY CUPS, R&R received FDA 510(k) clearance under submission number K780198, sponsored by Ransom and Randolph. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-02-16.
- Submission: K780198
- Applicant / Sponsor: Ransom and Randolph
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6290
- Decision date: 1978-02-16
Classification & Regulation
This clearance is catalogued under FDA product code EHK and 21 CFR 872.6290, within the Dental review panel as a Class I device.