Clearance Summary
C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO received FDA 510(k) clearance under submission number K000894, sponsored by Dental Ventures of America, 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 2000-05-19.
- Submission: K000894
- Applicant / Sponsor: Dental Ventures of America, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2000-05-19
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.