Maxibond
FDA 510(k) K884575 · Ortho Source
510(k) numberK884575
Submission
- Device name
- Maxibond
- Applicant
- Ortho Source
North Hollywood, CA, US - Received
- November 1, 1988
- Decision date
- January 3, 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 |
|---|---|---|
| K913853 | Fissure SealerEBC · Traditional | 08/27/1992SE |
| K913854 | Ortho Light CureDYH · Traditional | 01/14/1992SE |
| K913519 | Sumo Glass Ionomer CementEMA · Traditional | 11/19/1991SE |
| K884949 | Visible Light Cure Calcium Hydroxide LinerEJK · Traditional | 02/23/1989SE |
| K861118 | Orthojoin, Orthodontic AdhesiveDYH · Traditional | 05/02/1986SE |
| K861258 | Permaband (Orthodontic Adhesive)DYH · Traditional | 04/17/1986SE |
| K861245 | Orthosource Etch SystemsEBC · Traditional | 04/11/1986SE |
| K860959 | DependabondDYH · Traditional | 03/25/1986SE |
Questions and answers
When was Maxibond cleared by the FDA?
Maxibond (K884575) received a 510(k) decision of Substantially Equivalent on January 3, 1989, 63 days after the submission was received.
What is the product code of K884575?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.