Clearance Summary
DR DISPOSABLE PROPHY ANGLE MODEL H310 received FDA 510(k) clearance under submission number K060377, sponsored by Dental Resources. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-04-26.
- Submission: K060377
- Applicant / Sponsor: Dental Resources
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2006-04-26
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.