The following data is part of a premarket notification filed by Norian Corp. with the FDA for Norian Periodontal/dental Cement (pdc).
| Device ID | K983104 |
| 510k Number | K983104 |
| Device Name: | NORIAN PERIODONTAL/DENTAL CEMENT (PDC) |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | NORIAN CORP. 10260 BUBB RD. Cupertino, CA 95014 -4166 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins NORIAN CORP. 10260 BUBB RD. Cupertino, CA 95014 -4166 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-04 |
| Decision Date | 1999-02-12 |
| Summary: | summary |