Implant Direct Sybron Manufacturing LLC

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
17
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2172-2025Class IIThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, veMay 1, 2025
Z-2037-2023Class IILEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGMay 2, 2023
Z-0197-2022Class IIImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,September 23, 2021
Z-0198-2022Class IIImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,September 23, 2021
Z-1157-2020Class IIImplant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7October 11, 2019
Z-1041-2020Class IILegacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213October 7, 2019
Z-0364-2020Class IIImplant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, August 9, 2019
Z-1126-2020Class IISwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708January 9, 2019
Z-0791-2020Class IIImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, November 28, 2018
Z-0790-2020Class IIImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, November 28, 2018
Z-0363-2020Class IIImplant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmOctober 26, 2018
Z-0261-2020Class IIImplant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3September 6, 2018
Z-0018-2020Class IIImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx,August 8, 2018
Z-0010-2020Class IIImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, SterileAugust 7, 2018
Z-0089-2019Class IIImplant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implaMay 29, 2018
Z-2376-2018Class IIREPLANT 5.0mmD ABUTMENT, Part number 6050-52-60May 18, 2018
Z-1917-2018Class IIImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, SMarch 14, 2018
Z-0539-2018Class IIImplant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD PlatformJanuary 23, 2018
Z-1168-2018Class IISwishPlus Implant Intended for use in support for fixed bridgework.January 19, 2018
Z-1167-2018Class IISwishTapered Implant Intended for use in support for fixed bridgework.January 19, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K231087Guided Surgery KitAugust 16, 2023
K223535SMARTbase Abutment SystemJune 20, 2023
K222211Implant Direct Dental Implant Systems Portfolio - MR ConditionalFebruary 2, 2023
K202524Standard Sterilizable TrayJanuary 28, 2021
K201553Simply Iconic ImplantsJanuary 22, 2021
K200858Mini Sterilizable TrayAugust 6, 2020
K200265Surgical DrillsJune 30, 2020
K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fJune 25, 2020
K192218Custom Legacy and Custom InterActive Titanium AbutmentsMay 8, 2020
K191458Legacy SMARTBase AbutmentsOctober 10, 2019
K181359InterActive SMARTBase AbutmentsAugust 15, 2018
K162633Custom BarsJuly 24, 2017
K153509GPS Angled AbutmentAugust 26, 2016
K1430112014 InterActive/SwishActive SystemJuly 16, 2015
K142519InterActive Complete Surgical TrayApril 15, 2015
K130572INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMDecember 24, 2013
K131097LEGACY3 6MM LENGTH IMPLANTSAugust 22, 2013