Clearance Summary
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS received FDA 510(k) clearance under submission number K892937, sponsored by Dentsply Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1989-06-22.
- Submission: K892937
- Applicant / Sponsor: Dentsply Intl.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4210
- Decision date: 1989-06-22
Classification & Regulation
This clearance is catalogued under FDA product code JDZ and 21 CFR 888.4210, within the Orthopedic review panel as a Class I device.