The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Spectra System Dental Implants 2008.
Device ID | K090234 |
510k Number | K090234 |
Device Name: | SPECTRA SYSTEM DENTAL IMPLANTS 2008 |
Classification | Implant, Endosseous, Root-form |
Applicant | IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
Contact | Thomas Gottenbos |
Correspondent | Thomas Gottenbos 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 | 2009-01-30 |
Decision Date | 2009-05-15 |
Summary: | summary |