The following data is part of a premarket notification filed by Norian Corp. with the FDA for Dentoridge(tm) Hydroxyylapatite.
| Device ID | K882098 |
| 510k Number | K882098 |
| Device Name: | DENTORIDGE(TM) HYDROXYYLAPATITE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | NORIAN CORP. 1030 HAMILTON COURT Menlo Park, CA 94025 |
| Contact | Winston A Andrews |
| Correspondent | Winston A Andrews NORIAN CORP. 1030 HAMILTON COURT Menlo Park, CA 94025 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-06-13 |