Clearance Summary
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 received FDA 510(k) clearance under submission number K042828, sponsored by Young O/S, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-12-01.
- Submission: K042828
- Applicant / Sponsor: Young O/S, LLC
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2004-12-01
Classification & Regulation
This clearance is catalogued under FDA product code EKR and 21 CFR 872.4565, within the Dental review panel as a Class I device.