The following data is part of a premarket notification filed by Instrumentarium Dental, Palodex Group Oy with the FDA for Orthopantomograph Op300.
| Device ID | K093683 |
| 510k Number | K093683 |
| Device Name: | ORTHOPANTOMOGRAPH OP300 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300 |
| Contact | Matti Tulikoura |
| Correspondent | Matti Tulikoura 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 | 2009-11-30 |
| Decision Date | 2010-10-06 |
| Summary: | summary |