Clearance Summary
W & H ASSISTINA received FDA 510(k) clearance under submission number K010127, sponsored by A-Dec, 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 2001-10-05.
- Submission: K010127
- Applicant / Sponsor: A-Dec, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2001-10-05
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.