Allure MB Ceramic Brackets
FDA 510(k) K090454 · Dentsply Interntional
510(k) numberK090454
Submission
- Device name
- Allure MB Ceramic Brackets
- Applicant
- Dentsply Interntional
York, PA, US - Received
- February 23, 2009
- Decision date
- March 20, 2009
- 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 |
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| K201410 | VENUS Bracket, ROSE BracketNJM · Traditional | Gni Co., Ltd. | 03/12/2021SE |
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| K082973 | Ster-Mate Sterile Lavage KitELC · Traditional | 01/29/2009SE |
| K082974 | Mystique MB Ceramic BracketsNJM · Special | 11/07/2008SE |
| K081291 | Pre-Cemented Orthodontic Bracket System ExtensionDYH · Special | 05/22/2008SE |
| K080311 | Modified Temprx Esthetic Provisional SystemEBG · Traditional | 04/18/2008SE |
| K080246 | Composite Aligner ButtonNXC · Traditional | 04/11/2008SE |
| K080203 | Mta Root Canal SealerKIF · Traditional | 03/26/2008SE |
| K073173 | Self-Adhesive Resin CementEMA · Traditional | 01/23/2008SE |
| K073218 | Mta Advanced MaterialKIF · Traditional | 01/07/2008SE |
Questions and answers
When was Allure MB Ceramic Brackets cleared by the FDA?
Allure MB Ceramic Brackets (K090454) received a 510(k) decision of Substantially Equivalent on March 20, 2009, 25 days after the submission was received.
What is the product code of K090454?
The FDA product code is NJM – Bracket, Ceramic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.