ROSA Bracket

510(k) Number

K182672 ↗

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).

• 3M™ 4006-158 by 3M UNITEK CORPORATION
• APC™ PLUS Clarity™ ADVANCED 5006-225 by 3M UNITEK CORPORATION
• TRUKLEAR BRACKET by Ajw Technology Consultants, Inc.
• DAMON 4CLEAR by Ormco Corporation
• Inspire ICE aka Inspire ICE Clear Brackets by Ormco Corporation
• Alpha Pure by Koroad America
• S-Line by Biocetec Co., Ltd.
• Mei Ceramic Bracket by Orthosun Co., Ltd.
• IN-OVATION C by Dentsply International
• Clear21 246.2002-5 by World Class Technology Corporation

• 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 →