Medical Device Manufacturer · US , Palm Beach Gardens , FL

Biomet 3i - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2007

Recent clearances: Certain BellaTek Express and BellaTek Flex Abutments

12

Total

12

Cleared

0

Denied

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

12 devices

1-12 of 12

Cleared Jul 02, 2019

Certain BellaTek Express and BellaTek Flex Abutments

Cleared Dec 13, 2017

TSV BellaTek Encode Healing Abutments

Cleared Sep 21, 2017

Eztetic BellaTek Encode Healing Abutments

Cleared Nov 20, 2015

3i T3 Short Implants

Cleared Jan 08, 2014

3I T3(R) EXTERNAL HEX DENTAL IMPLANTS

Cleared Jul 30, 2013

CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS

Cleared Jun 21, 2013

CERTAIN BELLATEK PROVISIONAL ABUTMENTS

Cleared Jan 30, 2013

T3 DENTAL IMPLANT

Cleared Sep 11, 2012

ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION

Cleared Jan 13, 2012

ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION

Cleared May 13, 2011

ENDOBON XENOGRAFT GRANULES

Cleared May 14, 2007