Orthodaptic* Bonding Adhesive
FDA 510(k) K823851 · Johnson & Johnson Professionals, Inc.
510(k) numberK823851
Submission
- Device name
- Orthodaptic* Bonding Adhesive
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- December 22, 1982
- Decision date
- January 9, 1983
- 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 |
|---|---|---|
| K992173 | Siphonguard CSF Control DeviceJXG · Traditional | 04/07/2000SE |
| K991413 | Codman Ethisorb Dura PatchGXQ · Traditional | 03/13/2000SE |
| K991222 | Codman Microsensor Ventricular Catheter KitGWM · Traditional | 07/09/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | 12/18/1998SE |
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper)KWY · Traditional | 12/04/1998SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | 07/01/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
Questions and answers
When was Orthodaptic* Bonding Adhesive cleared by the FDA?
Orthodaptic* Bonding Adhesive (K823851) received a 510(k) decision of Substantially Equivalent on January 9, 1983, 18 days after the submission was received.
What is the product code of K823851?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.