Inspire ICE aka Inspire ICE Clear Brackets
FDA 510(k) K171844 · Ormco Corporation
510(k) numberK171844
Submission
- Device name
- Inspire ICE aka Inspire ICE Clear Brackets
- Applicant
- Ormco Corporation
Orange, CA, US - Received
- June 20, 2017
- Decision date
- July 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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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| K250487 | SparkTM Clear Aligner SystemNXC · Traditional | 02/20/2025SE |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | 01/03/2025SE |
| K240501 | Spark Clear Aligner SystemNXC · Traditional | 10/11/2024SE |
| K203737 | Spark Clear Aligner SystemNXC · Traditional | 03/22/2021SE |
| K172845 | Symetri ClearNJM · Traditional | 01/31/2018SE |
| K141611 | Lythos Digital Impression SystemNOF · Traditional | 12/05/2014SE |
| K123118 | Insignia DigicastDYW · Traditional | 03/26/2013SE |
| K123416 | Insignia with IteroDYW · Traditional | 03/13/2013SE |
| K122065 | Digital Impression System for Orthodontic UseNOF · Traditional | 02/08/2013SE |
| K121524 | InsigniaDYW · Traditional | 08/09/2012SE |
Questions and answers
When was Inspire ICE aka Inspire ICE Clear Brackets cleared by the FDA?
Inspire ICE aka Inspire ICE Clear Brackets (K171844) received a 510(k) decision of Substantially Equivalent on July 18, 2017, 28 days after the submission was received.
What is the product code of K171844?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.