The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Imperva Ensurabond.
| Device ID | K953613 |
| 510k Number | K953613 |
| Device Name: | IMPERVA ENSURABOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | William Oestreich |
| Correspondent | William Oestreich SHOFU DENTAL CORP. 4025 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1995-10-04 |