The following data is part of a premarket notification filed by Ney Dental, Inc. with the FDA for Excelsior Porcelain System.
| Device ID | K984427 |
| 510k Number | K984427 |
| Device Name: | EXCELSIOR PORCELAIN SYSTEM |
| Classification | Powder, Porcelain |
| Applicant | NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach, FL 33442 -8193 |
| Contact | Andrew J Pietrobono |
| Correspondent | Andrew J Pietrobono NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach, FL 33442 -8193 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-11 |
| Decision Date | 1999-03-15 |