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 |