The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Post Cement (dental Composite).
Device ID | K902894 |
510k Number | K902894 |
Device Name: | POST CEMENT (DENTAL COMPOSITE) |
Classification | Cement, Dental |
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 | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-02 |
Decision Date | 1990-08-01 |