Clearance Summary
MANI DIA-BURS received FDA 510(k) clearance under submission number K913651, sponsored by The Lahr Consulting Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-01-14.
- Submission: K913651
- Applicant / Sponsor: The Lahr Consulting Group, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4535
- Decision date: 1992-01-14
Classification & Regulation
This clearance is catalogued under FDA product code DZP and 21 CFR 872.4535, within the Dental review panel as a Class I device.