The following data is part of a premarket notification filed by Bonafix Surgical And Dental Implants, Llc with the FDA for Minifix Ball Minifix One.
Device ID | K122052 |
510k Number | K122052 |
Device Name: | MINIFIX BALL MINIFIX ONE |
Classification | Implant, Endosseous, Root-form |
Applicant | BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC 118 W. PRIVE CR. Delray Beach, FL 33445 |
Contact | Juan Tezak |
Correspondent | Juan Tezak BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC 118 W. PRIVE CR. Delray Beach, FL 33445 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-07-12 |
Decision Date | 2012-11-28 |
Summary: | summary |