The following data is part of a premarket notification filed by Cefla Dental Group with the FDA for Myray Hyperion.
| Device ID | K101661 |
| 510k Number | K101661 |
| Device Name: | MYRAY HYPERION |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | CEFLA DENTAL GROUP 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte, Ph.d. |
| Correspondent | Cynthia J Nolte, Ph.d. CEFLA DENTAL GROUP 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-14 |
| Decision Date | 2010-09-16 |
| Summary: | summary |