The following data is part of a premarket notification filed by Dexis Llc with the FDA for Dexis Sensor.
| Device ID | K090458 |
| 510k Number | K090458 |
| Device Name: | DEXIS SENSOR |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DEXIS LLC 1717 WEST COLLINS Orange, CA 92867 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz DEXIS LLC 1717 WEST COLLINS Orange, CA 92867 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-23 |
| Decision Date | 2009-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101289780 | K090458 | 000 |
| EKAV082245990 | K090458 | 000 |
| EKAV082250110 | K090458 | 000 |
| EKAV082250120 | K090458 | 000 |
| EKAV082250130 | K090458 | 000 |
| EKAV082250710 | K090458 | 000 |
| EKAV082250730 | K090458 | 000 |
| EKAV082250740 | K090458 | 000 |
| EKAV082251940 | K090458 | 000 |
| EKAV082245980 | K090458 | 000 |
| EKAV101305140 | K090458 | 000 |
| EKAV101291570 | K090458 | 000 |
| EKAV101291580 | K090458 | 000 |
| EKAV101291590 | K090458 | 000 |
| EKAV101291600 | K090458 | 000 |
| EKAV101291610 | K090458 | 000 |
| EKAV101305110 | K090458 | 000 |
| EKAV101305120 | K090458 | 000 |
| EKAV101305130 | K090458 | 000 |
| EKAV100730420 | K090458 | 000 |
| EKAV100762000 | K090458 | 000 |
| EKAV101076560 | K090458 | 000 |
| EKAV101078630 | K090458 | 000 |
| EKAV101078640 | K090458 | 000 |
| EKAV101081180 | K090458 | 000 |
| EKAV101081190 | K090458 | 000 |
| EKAV101184170 | K090458 | 000 |
| EKAV101184190 | K090458 | 000 |
| EKAV101289770 | K090458 | 000 |
| EKAV101076550 | K090458 | 000 |
| EKAV101076540 | K090458 | 000 |
| EKAV100762010 | K090458 | 000 |
| EKAV100762020 | K090458 | 000 |
| EKAV100850520 | K090458 | 000 |
| EKAV100850530 | K090458 | 000 |
| EKAV100850540 | K090458 | 000 |
| EKAV100850550 | K090458 | 000 |
| EKAV100898740 | K090458 | 000 |
| EKAV100898770 | K090458 | 000 |
| EKAV101291560 | K090458 | 000 |