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Biomet 3i, LLC

FDA Regulatory Profile

Summary

Total Recalls
222
510(k) Clearances
32
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0079-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6August 31, 2020
Z-0073-2021Class IIBellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQAugust 31, 2020
Z-0078-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5August 31, 2020
Z-0075-2021Class IICERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4August 31, 2020
Z-0077-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4August 31, 2020
Z-0076-2021Class IICERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5August 31, 2020
Z-0074-2021Class IIBELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4August 31, 2020
Z-1386-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHAJanuary 10, 2020
Z-1371-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356January 10, 2020
Z-1375-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453January 10, 2020
Z-1388-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574January 10, 2020
Z-1373-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444January 10, 2020
Z-1385-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHAJanuary 10, 2020
Z-1378-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463January 10, 2020
Z-1381-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474January 10, 2020
Z-1377-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456January 10, 2020
Z-1387-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566January 10, 2020
Z-1374-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446January 10, 2020
Z-1372-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443January 10, 2020
Z-1384-2020Class IICERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563January 10, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K251660T3 Pro Implants– ZimVie Packaging SystemJune 27, 2025
K241753Immediate Molar ImplantsOctober 23, 2024
K241032BellaTek BarsJuly 15, 2024
K220978TSX ImplantsSeptember 14, 2022
K213672T3 Pro ImplantsMarch 28, 2022
K212730BellaTek Encode Emergence Healing AbutmentsDecember 21, 2021
K192522TSV BellaTek Express and BellaTek Flex AbutmentsDecember 9, 2019
K183138Certain BellaTek Express and BellaTek Flex AbutmentsJuly 2, 2019
K173374TSV BellaTek Encode Healing AbutmentsDecember 13, 2017
K170013Eztetic BellaTek Encode Healing AbutmentsSeptember 21, 2017
K1505713i T3 Short ImplantsNovember 20, 2015
K1330493I T3(R) EXTERNAL HEX DENTAL IMPLANTSJanuary 8, 2014
K130949CP4 OSSEOTITE CERTAIN DENTAL IMPLANTSJuly 30, 2013
K130310CERTAIN BELLATEK PROVISIONAL ABUTMENTSJune 21, 2013
K122300T3 DENTAL IMPLANTJanuary 30, 2013
K120776ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTIONSeptember 11, 2012
K112730ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTIONJanuary 13, 2012
K111216OSSEOTITE 2 DENTAL IMPLANTSNovember 18, 2011
K110565ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACESeptember 1, 2011
K110449ENDOBON XENOGRAFT GRANULESMay 13, 2011