The following data is part of a premarket notification filed by Satelec with the FDA for Is 40 Micromotor.
| Device ID | K042787 |
| 510k Number | K042787 |
| Device Name: | IS 40 MICROMOTOR |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | SATELEC 130 GAITHER DRIVE SUITE 100 Mt. Laurel, NJ 08054 |
| Contact | Steve Salesky |
| Correspondent | Steve Salesky SATELEC 130 GAITHER DRIVE SUITE 100 Mt. Laurel, NJ 08054 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-12-17 |
| Summary: | summary |