The following data is part of a premarket notification filed by Whaledent Intl. Div. Ipco with the FDA for Unity Dental Cement.
| Device ID | K900342 |
| 510k Number | K900342 |
| Device Name: | UNITY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | WHALEDENT INTL. DIV. IPCO CONSULTANT 36 MAPLEWOOD ROAD Hartsdale, NY 10530 |
| Contact | Leonard Wolfson |
| Correspondent | Leonard Wolfson WHALEDENT INTL. DIV. IPCO CONSULTANT 36 MAPLEWOOD ROAD Hartsdale, NY 10530 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-05-07 |