The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Prodigy System Dental Implants.
| Device ID | K042429 |
| 510k Number | K042429 |
| Device Name: | THE PRODIGY SYSTEM DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Winston Greer |
| Correspondent | Winston Greer BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236005917 | K042429 | 000 |
| 00847236003951 | K042429 | 000 |
| 00847236003968 | K042429 | 000 |
| 00847236003975 | K042429 | 000 |
| 00847236003982 | K042429 | 000 |
| 00847236004033 | K042429 | 000 |
| 00847236004040 | K042429 | 000 |
| 00847236004057 | K042429 | 000 |
| 00847236004064 | K042429 | 000 |
| 00847236003944 | K042429 | 000 |
| 00847236003937 | K042429 | 000 |
| 00847236003777 | K042429 | 000 |
| 00847236003784 | K042429 | 000 |
| 00847236003791 | K042429 | 000 |
| 00847236003883 | K042429 | 000 |
| 00847236003890 | K042429 | 000 |
| 00847236003906 | K042429 | 000 |
| 00847236003913 | K042429 | 000 |
| 00847236003920 | K042429 | 000 |
| 00847236004071 | K042429 | 000 |
| 00847236004088 | K042429 | 000 |
| 00847236005139 | K042429 | 000 |
| 00847236005580 | K042429 | 000 |
| 00847236005634 | K042429 | 000 |
| 00847236005641 | K042429 | 000 |
| 00847236005870 | K042429 | 000 |
| 00847236005887 | K042429 | 000 |
| 00847236005894 | K042429 | 000 |
| 00847236005900 | K042429 | 000 |
| 00847236005122 | K042429 | 000 |
| 00847236005115 | K042429 | 000 |
| 00847236004095 | K042429 | 000 |
| 00847236004149 | K042429 | 000 |
| 00847236004156 | K042429 | 000 |
| 00847236004163 | K042429 | 000 |
| 00847236004170 | K042429 | 000 |
| 00847236004583 | K042429 | 000 |
| 00847236005092 | K042429 | 000 |
| 00847236005108 | K042429 | 000 |
| 00847236017378 | K042429 | 000 |