Clearance Summary
X-TIP INTRAOSSEOUS PERFORATOR received FDA 510(k) clearance under submission number K990511, sponsored by Schiff & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-04-27.
- Submission: K990511
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4730
- Decision date: 1999-04-27
Classification & Regulation
This clearance is catalogued under FDA product code DZM and 21 CFR 872.4730, within the Dental review panel as a Class I device.