The following data is part of a premarket notification filed by Delsan Dental Systems with the FDA for Minidam Ii.
| Device ID | K921771 |
| 510k Number | K921771 |
| Device Name: | MINIDAM II |
| Classification | Dam, Rubber |
| 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 | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1992-09-17 |