Clearance Summary
PREFORMED TOOTH POSITIONER received FDA 510(k) clearance under submission number K780619, sponsored by Tp Laboratories, 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 1978-06-28.
- Submission: K780619
- Applicant / Sponsor: Tp Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5525
- Decision date: 1978-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KMY and 21 CFR 872.5525, within the Dental review panel as a Class I device.