The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Spectra System.
Device ID | K061319 |
510k Number | K061319 |
Device Name: | SPECTRA SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
Contact | Leslie Terry |
Correspondent | Leslie Terry IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-11 |
Decision Date | 2006-09-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPECTRA SYSTEM 77356904 not registered Dead/Abandoned |
ALTMAN STAGE LIGHTING CO., INC. 2007-12-20 |
SPECTRA SYSTEM 74099730 1754937 Dead/Cancelled |
Spectra-Physics, Inc. 1990-09-24 |
SPECTRA SYSTEM 74034767 1695278 Dead/Cancelled |
Core-Vent Corporation 1990-03-02 |
SPECTRA SYSTEM 74007160 1676601 Dead/Cancelled |
SPECTRA SYSTEMS, INC. 1989-12-04 |