The following data is part of a premarket notification filed by Midwest with the FDA for Tradition High Speed Handpiece.
| Device ID | K863677 |
| 510k Number | K863677 |
| Device Name: | TRADITION HIGH SPEED HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | MIDWEST 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | James E Kettner |
| Correspondent | James E Kettner MIDWEST 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 | 1986-09-19 |
| Decision Date | 1986-10-06 |