The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Progeny Mpse Intraoral Dental X-ray Sensor.
| Device ID | K041831 |
| 510k Number | K041831 |
| Device Name: | PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Contact | E.m. Dolan |
| Correspondent | E.m. Dolan PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-07 |
| Decision Date | 2004-08-09 |
| Summary: | summary |