Genoss Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242386BluemoonMay 5, 2025
K222688The TrustAugust 9, 2024
K233885rainbow Paste Stain SEJune 21, 2024
K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoFebruary 23, 2024
K231480Bright MTA Sealer PlusJuly 28, 2023
K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright ImpreDecember 15, 2022
K200155Bright High FlowNovember 30, 2020
K200153Bright Bond UniversalOctober 28, 2020
K200156Bright Low FlowOctober 27, 2020
K170596TN-BrushSeptember 11, 2017
K160079rainbow ShineNovember 10, 2016
K153676OSTEON IIISeptember 14, 2016
K160144rainbow LS BlockJuly 21, 2016
K112716OSTEON IIJanuary 17, 2012
K102307GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSMay 4, 2011
K102015OSTEON, OSTEON SINUS, OSTEON LIFTINGNovember 19, 2010
K092513RAINBOW BLOCKOctober 9, 2009
K062834OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050April 24, 2007