The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Lite Fil Ii A.
| Device ID | K920892 |
| 510k Number | K920892 |
| Device Name: | LITE FIL II A |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SHOFU DENTAL CORP. 4024 BOHANNON DR. Menlo Park, CA 94025 -1096 |
| Contact | Richard D Stanley |
| Correspondent | Richard D Stanley 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 | 1992-02-26 |
| Decision Date | 1992-09-01 |