The following data is part of a premarket notification filed by Nouvag Ag with the FDA for Micro-dispenser 7000 & Microdispenser 8000.
| Device ID | K954722 |
| 510k Number | K954722 |
| Device Name: | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NOUVAG AG 555 THIRTEEN ST., N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein NOUVAG AG 555 THIRTEEN ST., N.W. Washington, DC 20004 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-01-16 |