The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Temporary Dental Cement.
| Device ID | K904034 |
| 510k Number | K904034 |
| Device Name: | TEMPORARY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Anand Akerkar |
| Correspondent | Anand Akerkar MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-31 |
| Decision Date | 1990-12-27 |