The following data is part of a premarket notification filed by Inclusive Dental Solutions with the FDA for Inclusive Zirconia Abutment Blanks.
| Device ID | K083480 |
| 510k Number | K083480 |
| Device Name: | INCLUSIVE ZIRCONIA ABUTMENT BLANKS |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-05-05 |
| Summary: | summary |