The following data is part of a premarket notification filed by Tpc Advanced Technology, Inc. with the FDA for Tpc Advancecam Intra Oral Camera System, Model Aic 888.
Device ID | K071485 |
510k Number | K071485 |
Device Name: | TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 |
Classification | Unit, Operative Dental |
Applicant | TPC ADVANCED TECHNOLOGY, INC. 18525 EAST GALE AVE. City Of Industry, CA 91748 |
Contact | Scott Beckley |
Correspondent | Scott Beckley TPC ADVANCED TECHNOLOGY, INC. 18525 EAST GALE AVE. City Of Industry, CA 91748 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-30 |
Decision Date | 2007-08-28 |
Summary: | summary |