The following data is part of a premarket notification filed by Bien-air Sa Switzerland with the FDA for Optima Mx.
| Device ID | K042759 |
| 510k Number | K042759 |
| Device Name: | OPTIMA MX |
| Classification | Unit, Operative Dental |
| Applicant | BIEN-AIR SA SWITZERLAND LANGASSE 60, CASE POSTALE Bienne 6, CH Ch-2500 |
| Contact | Alain Leonetti |
| Correspondent | Erin Sparnon CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2004-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D9501318601 | K042759 | 000 |
| D9501318500 | K042759 | 000 |
| D9501317701 | K042759 | 000 |