The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Simple Solutions With Laser-lok.
| Device ID | K100985 |
| 510k Number | K100985 |
| Device Name: | BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Contact | Michael Davis |
| Correspondent | Michael Davis BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236007362 | K100985 | 000 |
| 00847236007218 | K100985 | 000 |
| 00847236007201 | K100985 | 000 |
| 00847236007195 | K100985 | 000 |
| 00847236007188 | K100985 | 000 |
| 00847236007171 | K100985 | 000 |
| 00847236007164 | K100985 | 000 |
| 00847236007157 | K100985 | 000 |
| 00847236007140 | K100985 | 000 |
| 00847236007133 | K100985 | 000 |
| 00847236007126 | K100985 | 000 |
| 00847236007119 | K100985 | 000 |
| 00847236007225 | K100985 | 000 |
| 00847236007232 | K100985 | 000 |
| 00847236007249 | K100985 | 000 |
| 00847236007355 | K100985 | 000 |
| 00847236007348 | K100985 | 000 |
| 00847236007331 | K100985 | 000 |
| 00847236007324 | K100985 | 000 |
| 00847236007317 | K100985 | 000 |
| 00847236007300 | K100985 | 000 |
| 00847236007294 | K100985 | 000 |
| 00847236007287 | K100985 | 000 |
| 00847236007270 | K100985 | 000 |
| 00847236007263 | K100985 | 000 |
| 00847236007256 | K100985 | 000 |
| 00847236007102 | K100985 | 000 |