The following data is part of a premarket notification filed by Ney Dental, Inc. with the FDA for Symbioceram.
Device ID | K990629 |
510k Number | K990629 |
Device Name: | SYMBIOCERAM |
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 | 1999-02-26 |
Decision Date | 1999-03-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYMBIOCERAM 75411782 2714782 Dead/Cancelled |
DEGUDENT GMBH 1997-12-29 |