The following data is part of a premarket notification filed by Biomet 3i with the FDA for Abutment For Competitive Implant Nobel Active Connection.
Device ID | K120776 |
510k Number | K120776 |
Device Name: | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
Contact | Tamara West |
Correspondent | Tamara West BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-14 |
Decision Date | 2012-09-11 |
Summary: | summary |