The following data is part of a premarket notification filed by Satelec with the FDA for Suni Max.
| Device ID | K000049 |
| 510k Number | K000049 |
| Device Name: | SUNI MAX |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Contact | Jacqueline E Masse |
| Correspondent | Jacqueline E Masse SATELEC 70 WALNUT ST. Wellesley, MA 02481 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-04-04 |