The following data is part of a premarket notification filed by Delsan Dental Systems with the FDA for Minidam.
| Device ID | K921117 |
| 510k Number | K921117 |
| Device Name: | MINIDAM |
| Classification | Mouthpiece, Saliva Ejector |
| Applicant | DELSAN DENTAL SYSTEMS 108 HOWARD WAY Pennington, NJ 08534 |
| Contact | De Luca |
| Correspondent | De Luca DELSAN DENTAL SYSTEMS 108 HOWARD WAY Pennington, NJ 08534 |
| Product Code | DYN |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-05-05 |