PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR

System, X-ray, Extraoral Source, Digital

PROGENY, INC.

The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Progeny Mpse Intraoral Dental X-ray Sensor.

Pre-market Notification Details

Device IDK041831
510k NumberK041831
Device Name:PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove,  IL  60089
ContactE.m. Dolan
CorrespondentE.m. Dolan
PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove,  IL  60089
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-07
Decision Date2004-08-09
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.