Adhesive, Bracket and Conditioner Resin
FDA 510(k) K780334 · Rocky Mountain Orthodontics, Inc.
510(k) numberK780334
Submission
- Device name
- Adhesive, Bracket and Conditioner Resin
- Applicant
- Rocky Mountain Orthodontics, Inc.
Mchenry, IL, US - Received
- February 28, 1978
- Decision date
- March 28, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DYH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K895401 | Northernlights Orthodontic Bonding SystemEBF · Traditional | 12/04/1989SE |
| K843527 | Orthomite 111 AdhesiveDYH · Traditional | 10/18/1984SE |
| K780678 | Impression TrayEHY · Traditional | 04/28/1978SE |
| K780170 | Orthodontic Bracket PadsEJF · Traditional | 03/15/1978SE |
| K780205 | Orthodontic Buccal TubeDZD · Traditional | 02/16/1978SE |
Questions and answers
When was Adhesive, Bracket and Conditioner Resin cleared by the FDA?
Adhesive, Bracket and Conditioner Resin (K780334) received a 510(k) decision of Substantially Equivalent on March 28, 1978, 28 days after the submission was received.
What is the product code of K780334?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.