The following data is part of a premarket notification filed by Instrumentarium Dental, Palodex Group Oy with the FDA for Orthopantomograph Op30.
| Device ID | K092591 |
| 510k Number | K092591 |
| Device Name: | ORTHOPANTOMOGRAPH OP30 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300 |
| Contact | Jouni Onnela |
| Correspondent | Jouni Onnela INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872718 | K092591 | 000 |
| 06430035872350 | K092591 | 000 |
| 06430035872367 | K092591 | 000 |
| 06430035872411 | K092591 | 000 |
| 06430035872428 | K092591 | 000 |
| 06430035872435 | K092591 | 000 |
| 06430035872442 | K092591 | 000 |
| 06430035872688 | K092591 | 000 |
| 06430035872701 | K092591 | 000 |
| 06430035874453 | K092591 | 000 |