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 |