CDB Self Ligating Bracket 8F
FDA 510(k) K160957 · Cdb Corporation
510(k) numberK160957
Submission
- Device name
- CDB Self Ligating Bracket 8F
- Applicant
- Cdb Corporation
Leland, NC, US - Received
- April 5, 2016
- Decision date
- September 27, 2016
- 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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| K222764 | LightForce Orthodontic SystemNJM · Special | Lightforce Orthodontics | 09/14/2022SE |
| K220689 | Vatech ClismileNJM · Traditional | Rayence Co., Ltd. | 05/06/2022SE |
| 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 |
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| 510(k) | Device | Decision |
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| K212173 | HDH Treatment Planning SystemPNN · Traditional | 01/25/2022SE |
| K210613 | HIT Clear AlignerNXC · Special | 06/04/2021SE |
| K191823 | Clear-AlignersNXC · Traditional | 12/20/2019SE |
| K091702 | CDB Flip-Side-Clip BracketNJM · Traditional | 08/07/2009SE |
| K080906 | CDB ClipNJM · Traditional | 10/17/2008SE |
| K973776 | ReflectionsDYW · Traditional | 11/21/1997SE |
| K934881 | ReflectionsEJF · Traditional | 02/01/1994SE |
| K922499 | Reflections - Ceramic Dental BracketEJF · Traditional | 07/30/1992SE |
Questions and answers
When was CDB Self Ligating Bracket 8F cleared by the FDA?
CDB Self Ligating Bracket 8F (K160957) received a 510(k) decision of Substantially Equivalent on September 27, 2016, 175 days after the submission was received.
What is the product code of K160957?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.