Clearance Summary
DEN-Z-ORB received FDA 510(k) clearance under submission number K780400, sponsored by Nice-Pak Products, 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 1978-03-27.
- Submission: K780400
- Applicant / Sponsor: Nice-Pak Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1978-03-27
Classification & Regulation
This clearance is catalogued under FDA product code KHR and 21 CFR 872.6050, within the Dental review panel as a Class I device.