The following data is part of a premarket notification filed by Implant Center Of The Palm Beaches with the FDA for Kis-ii Implant System/drills.
| Device ID | K944356 |
| 510k Number | K944356 |
| Device Name: | KIS-II IMPLANT SYSTEM/DRILLS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach, FL 33408 |
| Contact | Jack T Krauser |
| Correspondent | Jack T Krauser IMPLANT CENTER OF THE PALM BEACHES 824 US HWY I, STE. 370 N. Palm Beach, FL 33408 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-12-05 |