Medical Device Manufacturer · US , Palm Beach Gardens , FL

Biomet 3i, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2007

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomet 3i, Inc. Dental ✕

13 devices

1-12 of 13

Cleared Nov 18, 2011

OSSEOTITE 2 DENTAL IMPLANTS

Cleared Sep 01, 2011

ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE

Cleared Apr 01, 2011

OSSEOTITE II MODEL XIFOSSXXX

Cleared Mar 11, 2011

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS

Cleared Mar 11, 2011

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS

Cleared Dec 03, 2010

ENCODE PATIENT SPECIFIC ABUTMENT

Cleared Nov 08, 2010

CAM STRUCTSURE BARS

Cleared Nov 30, 2009

LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION

Cleared Jul 21, 2008

CAM STRUCTSURE PRECISION MILLED BARS

Cleared Mar 07, 2008

CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT

Cleared Jan 31, 2008

NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX

Cleared Dec 20, 2007

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026