VENUS Bracket, ROSE Bracket

510(k) Number

K201410 ↗

FDA product code

NJM

FDA applicant

Gni Co., Ltd.

Device class

Class II

Regulation

21 CFR Part 872.5470

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code NJM (Bracket, Ceramic, Orthodontic).

• APC™ PLUS Clarity™ ADVANCED 5006-202 by 3M UNITEK CORPORATION
• APC™ PLUS Clarity™ ADVANCED 5006-252 by 3M UNITEK CORPORATION
• MACH BRACKETS BRIGHT BRACKETS by World Bio Tech Co., Ltd.
• C-Line Orthodontic Ceramic Bracket by Biocetec Co., Ltd.
• Clear21 246.21559999999999 by World Class Technology Corporation
• Ceramic Brackets by Ortho Organizers, Inc.
• INTRIGUE CERAMIC BRACKET by LANCER ORTHODONTICS, INC.
• Clear21 246.20320000000001 by World Class Technology Corporation
• Avex CX2 by Opal Orthodontics by Ultradent Products
• Luce Ceramic Bracket by Luce Castle Co., Ltd.

• M1E-18-301

  Class I

  GUDID on market

• Var-22-501

  Class II

  FDA 510(k) K201410 Active Cleared 12 Mar 2021 GUDID on market

• SA1208C

  Class II

  GUDID on market

• Rcr-18-503

  Class II

  FDA 510(k) K201410 Active Cleared 12 Mar 2021 GUDID on market

See all devices from GNI Co., Ltd →