Heliosit-Orthodontic
FDA 510(k) K823409 · Vivadent (Usa), Inc.
510(k) numberK823409
Submission
- Device name
- Heliosit-Orthodontic
- Applicant
- Vivadent (Usa), Inc.
Amherst, NY, US - Received
- November 15, 1982
- Decision date
- January 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
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| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | Ormco Corporation | 01/03/2025SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | American Orthodontics Corp. | 08/27/2024SE |
| K234043 | 3M Transbond Orthodontic AdhesiveDYH · Traditional | 3M Unitek Orthodontic Products | 12/22/2023SE |
| K231817 | AlignerFlow LCDYH · Traditional | Voco GmbH | 12/01/2023SE |
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| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | American Orthodontics | 08/14/2020SE |
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K863831 | Vivadent FilpinEBL · Traditional | 10/14/1986SE |
| K813015 | HeliosealEBC · Traditional | 12/02/1981SE |
| K802679 | SilanitEBG · Traditional | 12/17/1980SE |
| K802684 | HeliomatEAY · Traditional | 11/24/1980SE |
| K802683 | HeliositEBF · Traditional | 11/24/1980SE |
| K802682 | Contact SealEBC · Traditional | 11/24/1980SE |
| K802681 | HeliobondKLE · Traditional | 11/24/1980SE |
| K802685 | ReolitEJK · Traditional | 11/12/1980SE |
| K802680 | Isopast-DsEBF · Traditional | 11/12/1980SE |
| K801227 | SilicapEMA · Traditional | 08/12/1980SE |
Questions and answers
When was Heliosit-Orthodontic cleared by the FDA?
Heliosit-Orthodontic (K823409) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 67 days after the submission was received.
What is the product code of K823409?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.