The following data is part of a premarket notification filed by The Implant Center Of The Palm Beaches with the FDA for Kis Mt5.
Device ID | K960112 |
510k Number | K960112 |
Device Name: | KIS MT5 |
Classification | Implant, Endosseous, Root-form |
Applicant | THE IMPLANT CENTER OF THE PALM BEACHES 824 U.S HIGHWAY 1 SUITE 370 North Palm Beach, FL 33408 |
Contact | Jack T Krauser |
Correspondent | Jack T Krauser THE IMPLANT CENTER OF THE PALM BEACHES 824 U.S HIGHWAY 1 SUITE 370 North 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 | 1996-01-11 |
Decision Date | 1996-03-15 |
Summary: | summary |