An Alternative Direct Bonding Ortho. System
FDA 510(k) K893396 · American Orthodontics
510(k) numberK893396
Submission
- Device name
- An Alternative Direct Bonding Ortho. System
- Applicant
- American Orthodontics
Sheboygan, WI, US - Received
- May 1, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
| K261840 | BracePaste Prime PlusDYH · Traditional | American Orthodontics | 06/03/2026SE |
| 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 |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional | Tp Orthodontics, Inc. | 10/14/2022SE |
| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | American Orthodontics | 08/14/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K261840 | BracePaste Prime PlusDYH · Traditional | 06/03/2026SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | 08/27/2024SE |
| K232011 | CleoNJM · Traditional | 07/07/2023SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | 08/14/2020SE |
| K181910 | BracePaste MTP Light Cure PrimerKLE · Traditional | 10/15/2018SE |
| K172953 | Acid EtchantKLE · Traditional | 02/06/2018SE |
| K160782 | BracePaste AdhesiveDYH · Traditional | 10/14/2016SE |
| K143117 | Wire Sterilization Package with IndicatorsFRG · Traditional | 10/29/2015SE |
| K122753 | Empower ClearNJM · Traditional | 12/14/2012SE |
| K080749 | RadianceNJM · Traditional | 08/04/2008SE |
Questions and answers
When was An Alternative Direct Bonding Ortho. System cleared by the FDA?
An Alternative Direct Bonding Ortho. System (K893396) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 53 days after the submission was received.
What is the product code of K893396?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.