Prime-Dent One-Step Orthodontic Adhesive Bonding System
FDA 510(k) K012673 · Prime Dental Manufacturing, Inc.
510(k) numberK012673
Submission
- Device name
- Prime-Dent One-Step Orthodontic Adhesive Bonding System
- Applicant
- Prime Dental Manufacturing, Inc.
Chicago, IL, US - Received
- August 14, 2001
- Decision date
- October 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K112574 | Prime-Dent Dual Cure Composite Luting CementEMA · Traditional | 01/23/2012SE |
| K022675 | Prime-Dent Automix Dual Cure Core Build Up MaterialEBF · Traditional | 11/07/2002SE |
| K021524 | Light Cure Dental DamEIE · Traditional | 07/19/2002SE |
| K013970 | Prime-Dent Hema DesensitizerEBF · Traditional | 02/19/2002SE |
| K012794 | Prime-Dent Chemical Cure Pit & Fissure SealantEBF · Traditional | 11/05/2001SE |
| K012761 | Prime-Dent Visible Light Cure Pit & Fissure SealantEBC · Traditional | 11/01/2001SE |
| K001108 | Prime-Dent Visible Light Cure Composite Restorative MaterialEBF · Traditional | 05/30/2000SE |
| K994224 | Prime-Dent Chemical Cure Composite Restorative MaterialEBF · Traditional | 01/31/2000SE |
Questions and answers
When was Prime-Dent One-Step Orthodontic Adhesive Bonding System cleared by the FDA?
Prime-Dent One-Step Orthodontic Adhesive Bonding System (K012673) received a 510(k) decision of Substantially Equivalent on October 24, 2001, 71 days after the submission was received.
What is the product code of K012673?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.