SANKO INTRAORAL DENTAL X-RAY

Unit, X-ray, Extraoral With Timer

SANKO X-RAY MANUFACTURING CO., LTD.

The following data is part of a premarket notification filed by Sanko X-ray Manufacturing Co., Ltd. with the FDA for Sanko Intraoral Dental X-ray.

Pre-market Notification Details

Device IDK972921
510k NumberK972921
Device Name:SANKO INTRAORAL DENTAL X-RAY
ClassificationUnit, X-ray, Extraoral With Timer
Applicant SANKO X-RAY MANUFACTURING CO., LTD. 904 KEMPSVILLE RD., SUITE 103 Virginia Beach,  VA  23464
ContactWarren E Sachs
CorrespondentWarren E Sachs
SANKO X-RAY MANUFACTURING CO., LTD. 904 KEMPSVILLE RD., SUITE 103 Virginia Beach,  VA  23464
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-08
Decision Date1998-01-06

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.