The following data is part of a premarket notification filed by Midwest Dental Products Corp. with the FDA for Midwest One.
| Device ID | K955655 |
| 510k Number | K955655 |
| Device Name: | MIDWEST ONE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Hector Jimenez |
| Correspondent | Hector Jimenez MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-03-05 |