Clearance Summary
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE received FDA 510(k) clearance under submission number K992893, sponsored by Mrlb Intl., Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-09-08.
- Submission: K992893
- Applicant / Sponsor: Mrlb Intl., Inc.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1999-09-08
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.