The following data is part of a premarket notification filed by Inclusive Dental Solutions with the FDA for Inclusive Implant Abutments.
Device ID | K073217 |
510k Number | K073217 |
Device Name: | INCLUSIVE IMPLANT ABUTMENTS |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | INCLUSIVE DENTAL SOLUTIONS 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
Contact | Keith D Allred |
Correspondent | Keith D Allred INCLUSIVE DENTAL SOLUTIONS 4141 MACARTHUR BLVD Newport Beach, CA 92660 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-15 |
Decision Date | 2008-05-14 |
Summary: | summary |