The following data is part of a premarket notification filed by Midwest Dental Products Corp. with the FDA for Microjet Cavity Preparation System.
| Device ID | K964755 |
| 510k Number | K964755 |
| Device Name: | MICROJET CAVITY PREPARATION SYSTEM |
| Classification | Airbrush |
| Applicant | MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Contact | Hector Jimenez-billini |
| Correspondent | Hector Jimenez-billini MIDWEST DENTAL PRODUCTS CORP. 901 WEST OAKTON ST. Des Plaines, IL 60018 |
| Product Code | KOJ |
| CFR Regulation Number | 872.6080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-09-11 |