Vatech Clismile

510(k) Number

K220689 ↗

FDA product code

NJM

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 5006-116 by 3M UNITEK CORPORATION
• APC™ PLUS Clarity™ ADVANCED 5006-364 by 3M UNITEK CORPORATION
• SAPPHIRE CERAMIC BRACKET by ORTHO TECHNOLOGY, INC.
• BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS by Forestadent Bernhard Förster GmbH
• ROSA Bracket by GNI Co., Ltd
• NEO-CLIP ORTHODONTIC BRACKET ACCESSORY by Dentsply Intl.
• Orthodontics Bracket by Speed Dental Co., Ltd.
• A-Line Advanced by Biocetec Co., Ltd.
• Clear21 246.2012-5 by World Class Technology Corporation
• Clear21 246.2011-5 by World Class Technology Corporation

• Intra Oral Sensor for dental imaging system used to convert X rays into Images

  Class IIa

  CE/MDR

• EzSensor UHD

  Class IIa

  CE/MDR

• Medical Image Processing Unit (Flat Panel Detector)

  Class IIa

  CE/MDR

• 0909FCE

  Class II

  FDA 510(k) K253800 Active Cleared 31 Jul 2026 GUDID on market

See all devices from Rayence Co., Ltd. →