Medical Device Manufacturer · US , Laguna Niguel , CA

Genoss Co., Ltd.

18 submissions · 18 cleared · Since 2007
18
Total
18
Cleared
0
Denied

Genoss Co., Ltd. — FDA 510(k) Submissions

Genoss Co., Ltd. has submitted 18 FDA 510(k) premarket notifications since 2007, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powder, Porcelain, Bone Grafting Material, Synthetic, Material, Tooth Shade, Resin, Agent, Tooth Bonding, Resin, Material, Impression . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
Bluemoon
K242386 · EBZ Activator, Ultraviolet,... · Dental
May 2025 266d
The Trust
K222688 · EKX Handpiece, Direct Drive,... · Dental
Aug 2024 703d
rainbow Paste Stain SE
K233885 · EIH Powder, Porcelain · Dental
Jun 2024 196d
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
K232174 · EIH Powder, Porcelain · Dental
Feb 2024 217d
Bright MTA Sealer Plus
K231480 · KIF Resin, Root Canal Filling · Dental
Jul 2023 67d
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
K214086 · ELW Material, Impression · Dental
Dec 2022 353d
Bright High Flow
K200155 · EBF Material, Tooth Shade, Resin · Dental
Nov 2020 313d
Bright Bond Universal
K200153 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2020 280d
Bright Low Flow
K200156 · EBF Material, Tooth Shade, Resin · Dental
Oct 2020 279d
TN-Brush
K170596 · ELB Scaler, Rotary · Dental
Sep 2017 195d
rainbow Shine
K160079 · EIH Powder, Porcelain · Dental
Nov 2016 301d
OSTEON III
K153676 · LYC Bone Grafting Material,... · Dental
Sep 2016 268d
rainbow LS Block
K160144 · EIH Powder, Porcelain · Dental
Jul 2016 182d
OSTEON II
K112716 · LYC Bone Grafting Material,... · Dental
Jan 2012 120d
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307 · NPL Barrier, Animal Source,... · Dental
May 2011 261d
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · LYC Bone Grafting Material,... · Dental
Nov 2010 126d
RAINBOW BLOCK
K092513 · EIH Powder, Porcelain · Dental
Oct 2009 53d
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K062834 · LYC Bone Grafting Material,... · Dental
Apr 2007 215d
Filters
All18 Dental 18