Vatech Clismile
FDA 510(k) K220689 · Rayence Co., Ltd.
510(k) numberK220689
Submission
- Device name
- Vatech Clismile
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- March 9, 2022
- Decision date
- May 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJM – Bracket, Ceramic, Orthodontic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Specialty
- Dental
An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
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|---|---|---|---|
| K232827 | LightForce Orthodontic SystemNJM · Traditional | Lightforce Orthodontics | 09/14/2023SE |
| K232011 | CleoNJM · Traditional | American Orthodontics | 07/07/2023SE |
| K231635 | A-Line AdvancedNJM · Traditional | Biocetec Co., Ltd. | 06/06/2023SE |
| K230225 | DynaFlex Clear Brackets & ButtonsNJM · Traditional | Dyna Flex | 06/05/2023SE |
| K222847 | Ceramic Brackets OrthometricNJM · Traditional | Orthometric - Industria E Comercio DE Produtos… | 05/04/2023SE |
| K222764 | LightForce Orthodontic SystemNJM · Special | Lightforce Orthodontics | 09/14/2022SE |
| K201410 | VENUS Bracket, ROSE BracketNJM · Traditional | Gni Co., Ltd. | 03/12/2021SE |
| K201038 | Luce Ceramic BracketNJM · Traditional | Luce Castle Co., Ltd. | 10/09/2020SE |
| K200148 | LightForce Orthodontic System (LFO System)NJM · Traditional | Lightforce Orthodontics | 02/21/2020SE |
| K182672 | ROSA BracketNJM · Traditional | Gni Co., Ltd. | 11/15/2019SE |
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| 510(k) | Device | Decision |
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| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQB · Traditional | 09/09/2024SE |
| K240371 | 0909FCC, 0909FCC-HSMQB · Special | 03/07/2024SE |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQB · Special | 06/21/2023SE |
| K212753 | 0909FCB, 1212FCAMQB · Special | 10/18/2021SE |
| K202902 | 2430MCA with Xmaru WMUE · Traditional | 06/21/2021SE |
| K210985 | 1717FCCMQB · Special | 04/28/2021SE |
| K202722 | 1212FCAMQB · Special | 10/26/2020SE |
| K201796 | 1717SCV, 1717SGVMQB · Special | 07/23/2020SE |
Questions and answers
When was Vatech Clismile cleared by the FDA?
Vatech Clismile (K220689) received a 510(k) decision of Substantially Equivalent on May 6, 2022, 58 days after the submission was received.
What is the product code of K220689?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.