The following data is part of a premarket notification filed by Inclusive Dental Solutions with the FDA for Inclusive Titanium Abutment Blanks.
| Device ID | K083192 |
| 510k Number | K083192 |
| Device Name: | INCLUSIVE TITANIUM 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 | 2008-10-29 |
| Decision Date | 2009-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701048COM00660 | K083192 | 000 |
| H65890105730 | K083192 | 000 |
| H65890105740 | K083192 | 000 |
| H65890105760 | K083192 | 000 |
| H65890105770 | K083192 | 000 |
| H65890105780 | K083192 | 000 |
| H65890105790 | K083192 | 000 |
| H65890105810 | K083192 | 000 |
| H65890105820 | K083192 | 000 |
| H65890105720 | K083192 | 000 |
| H65890105710 | K083192 | 000 |
| H65890105250 | K083192 | 000 |
| H65890105260 | K083192 | 000 |
| H65890105270 | K083192 | 000 |
| H65890105280 | K083192 | 000 |
| H65890105300 | K083192 | 000 |
| H65890105310 | K083192 | 000 |
| H65890105330 | K083192 | 000 |
| H65890105340 | K083192 | 000 |
| H65890105840 | K083192 | 000 |
| H65890105850 | K083192 | 000 |
| H65890107130 | K083192 | 000 |
| H65890107160 | K083192 | 000 |
| H65890107170 | K083192 | 000 |
| H65890107180 | K083192 | 000 |
| H65890107190 | K083192 | 000 |
| H65890107200 | K083192 | 000 |
| D745701048COM00640 | K083192 | 000 |
| D745701048COM00650 | K083192 | 000 |
| H65890107110 | K083192 | 000 |
| H65890107100 | K083192 | 000 |
| H65890105860 | K083192 | 000 |
| H65890105870 | K083192 | 000 |
| H65890105880 | K083192 | 000 |
| H65890107050 | K083192 | 000 |
| H65890107060 | K083192 | 000 |
| H65890107070 | K083192 | 000 |
| H65890107080 | K083192 | 000 |
| H65890107090 | K083192 | 000 |
| H65890105230 | K083192 | 000 |