Clearance Summary
DENTAL PROPHY CUPS (VARIOUS TYPES) received FDA 510(k) clearance under submission number K864059, sponsored by Mission White Dental, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-11-19.
- Submission: K864059
- Applicant / Sponsor: Mission White Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6290
- Decision date: 1986-11-19
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.