Biomet 3i is one of 12950 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biomet 3i - FDA 510(k) Cleared Devices
Recent clearances: Certain BellaTek Express and BellaTek Flex Abutments, TSV BellaTek Encode Healing Abutments, Eztetic BellaTek Encode Healing Abutments
12
Total
12
Cleared
0
Denied
Biomet 3i has 12 FDA 510(k) cleared dental devices. Based in Palm Beach Gardens, US.
Historical record: 12 cleared submissions from 2007 to 2019.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by PaxMed International, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Biomet 3i
12 devices
Cleared
Jul 02, 2019
Certain BellaTek Express and BellaTek Flex Abutments
Dental
231d
Cleared
Dec 13, 2017
TSV BellaTek Encode Healing Abutments
Dental
47d
Cleared
Sep 21, 2017
Eztetic BellaTek Encode Healing Abutments
Dental
261d
Cleared
Nov 20, 2015
3i T3 Short Implants
Dental
259d
Cleared
Jan 08, 2014
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
Dental
103d
Cleared
Jul 30, 2013
CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
Dental
116d
Cleared
Jun 21, 2013
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
Dental
134d
Cleared
Jan 30, 2013
T3 DENTAL IMPLANT
Dental
183d
Cleared
Sep 11, 2012
ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION
Dental
181d
Cleared
Jan 13, 2012
ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION
Dental
115d
Cleared
May 13, 2011
ENDOBON XENOGRAFT GRANULES
Dental
86d
Cleared
May 14, 2007
INTERGRO ORAL
Dental
118d