The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Imperva-a.
| Device ID | K871899 |
| 510k Number | K871899 |
| Device Name: | IMPERVA-A |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Akerkar, Ph.d. |
| Correspondent | Akerkar, Ph.d. SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-15 |
| Decision Date | 1987-07-21 |