The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Ti-core (dental Composite).
| Device ID | K902893 |
| 510k Number | K902893 |
| Device Name: | TI-CORE (DENTAL COMPOSITE) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Akerkar, Ph.d. |
| Correspondent | Akerkar, Ph.d. MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-09-06 |