The following data is part of a premarket notification filed by Global Dental Products, Inc. with the FDA for Cimofluor.
| Device ID | K023888 |
| 510k Number | K023888 |
| Device Name: | CIMOFLUOR |
| Classification | Cement, Dental |
| Applicant | GLOBAL DENTAL PRODUCTS, INC. PO BOX 537 North Bellmore, NY 11710 |
| Contact | Jerry L Bartick |
| Correspondent | Jerry L Bartick GLOBAL DENTAL PRODUCTS, INC. PO BOX 537 North Bellmore, NY 11710 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-21 |
| Decision Date | 2003-03-05 |