The following data is part of a premarket notification filed by Instrumentarium Dental, Palodex Group Oy with the FDA for Digora Optime.
| Device ID | K133231 |
| 510k Number | K133231 |
| Device Name: | DIGORA OPTIME |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300 |
| Contact | Terho Turkumaki |
| Correspondent | Terho Turkumaki INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035872480 | K133231 | 000 |
| 06430035873227 | K133231 | 000 |
| 06430035873210 | K133231 | 000 |
| 06430035873203 | K133231 | 000 |
| 06430035873197 | K133231 | 000 |
| 06430035873180 | K133231 | 000 |
| 06430035873173 | K133231 | 000 |
| 06430035873166 | K133231 | 000 |
| 06430035873159 | K133231 | 000 |
| 06430035873142 | K133231 | 000 |
| 06430035873135 | K133231 | 000 |
| 06430035873128 | K133231 | 000 |
| 06430035873234 | K133231 | 000 |
| 06430035873241 | K133231 | 000 |
| 06430035873258 | K133231 | 000 |
| 06430035873661 | K133231 | 000 |
| 06430035873654 | K133231 | 000 |
| 06430035873647 | K133231 | 000 |
| 06430035873395 | K133231 | 000 |
| 06430035873326 | K133231 | 000 |
| 06430035873319 | K133231 | 000 |
| 06430035873302 | K133231 | 000 |
| 06430035873296 | K133231 | 000 |
| 06430035873289 | K133231 | 000 |
| 06430035873272 | K133231 | 000 |
| 06430035873265 | K133231 | 000 |
| 06430035873043 | K133231 | 000 |