Clearance Summary
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 received FDA 510(k) clearance under submission number K071485, sponsored by Tpc Advanced Technology, 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 2007-08-28.
- Submission: K071485
- Applicant / Sponsor: Tpc Advanced Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2007-08-28
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.