The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Laser-lok Abutments For Nobel Biocare.
| Device ID | K103291 |
| 510k Number | K103291 |
| Device Name: | BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE |
| 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 | 2010-11-08 |
| Decision Date | 2011-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236003593 | K103291 | 000 |
| 00847236003357 | K103291 | 000 |
| 00847236003340 | K103291 | 000 |
| 00847236003333 | K103291 | 000 |
| 00847236003326 | K103291 | 000 |
| 00847236003319 | K103291 | 000 |
| 00847236003302 | K103291 | 000 |
| 00847236003296 | K103291 | 000 |
| 00847236003289 | K103291 | 000 |
| 00847236003272 | K103291 | 000 |
| 00847236003265 | K103291 | 000 |
| 00847236003258 | K103291 | 000 |
| 00847236003241 | K103291 | 000 |
| 00847236003234 | K103291 | 000 |
| 00847236003227 | K103291 | 000 |
| 00847236003210 | K103291 | 000 |
| 00847236003364 | K103291 | 000 |
| 00847236003371 | K103291 | 000 |
| 00847236003388 | K103291 | 000 |
| 00847236003579 | K103291 | 000 |
| 00847236003562 | K103291 | 000 |
| 00847236003555 | K103291 | 000 |
| 00847236003548 | K103291 | 000 |
| 00847236003531 | K103291 | 000 |
| 00847236003524 | K103291 | 000 |
| 00847236003500 | K103291 | 000 |
| 00847236003470 | K103291 | 000 |
| 00847236003456 | K103291 | 000 |
| 00847236003449 | K103291 | 000 |
| 00847236003432 | K103291 | 000 |
| 00847236003425 | K103291 | 000 |
| 00847236003418 | K103291 | 000 |
| 00847236003401 | K103291 | 000 |
| 00847236003395 | K103291 | 000 |
| 00847236003203 | K103291 | 000 |