In-Ovation C
FDA 510(k) K060837 · Dentsply International
510(k) numberK060837
Submission
- Device name
- In-Ovation C
- Applicant
- Dentsply International
York, PA, US - Received
- March 28, 2006
- Decision date
- April 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K151039 | ATLANTIS Abutment for NobelActive 3.0NHA · Traditional | 01/14/2016SE |
| K151619 | Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional | 10/30/2015SE |
| K150535 | Cavitron Touch Ultrasonic Scaling SystemELC · Traditional | 06/16/2015SE |
| K142178 | Proroot Mta White, Proroot Mta GrayKIF · Traditional | 02/26/2015SE |
| K131907 | Raypex 6LQY · Traditional | 01/31/2014SE |
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Questions and answers
When was In-Ovation C cleared by the FDA?
In-Ovation C (K060837) received a 510(k) decision of Substantially Equivalent on April 10, 2006, 13 days after the submission was received.
What is the product code of K060837?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.