Clearance Summary
B&L L-BETA, MODEL WL-B1 received FDA 510(k) clearance under submission number K060347, sponsored by B&L Biotech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-06-05.
- Submission: K060347
- Applicant / Sponsor: B&L Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2006-06-05
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.