Clearance Summary
I-TEC PORTABLE DENTAL OPERATORY received FDA 510(k) clearance under submission number K040153, sponsored by Indigenous Peoples Technology and Education Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2004-05-21.
- Submission: K040153
- Applicant / Sponsor: Indigenous Peoples Technology and Education Center
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2004-05-21
Classification & Regulation
This clearance is catalogued under FDA product code EBW and 21 CFR 872.4200, within the Dental review panel as a Class I device.