Clearance Summary
ENDODONTIC INSTRUMENTS, R&R CUTWELL received FDA 510(k) clearance under submission number K770598, 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 1977-04-05.
- Submission: K770598
- Applicant / Sponsor: Ransom and Randolph
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1977-04-05
Classification & Regulation
This clearance is catalogued under FDA product code EKP and 21 CFR 872.4565, within the Dental review panel as a Class I device.