Orthodontic Bracket Adhesive Resin Material
FDA 510(k) K914317 · Confi-Dental Products Co.
510(k) numberK914317
Submission
- Device name
- Orthodontic Bracket Adhesive Resin Material
- Applicant
- Confi-Dental Products Co.
Louisville, CO, US - Received
- September 26, 1991
- Decision date
- March 26, 1992
- 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 |
|---|---|---|
| K030807 | Caries IndicatorLFC · Traditional | 06/09/2003SE |
| K030743 | Etchant 40%KLE · Traditional | 05/09/2003SE |
| K955329 | Resilience M5 Protection PlusDYH · Traditional | 03/28/1996SE |
| K955328 | Confi-BondKLE · Traditional | 03/28/1996SE |
| K954988 | CrystallessenceEBF · Traditional | 03/08/1996SE |
| K952930 | Dentray II Plus Tray AdhesiveELW · Traditional | 09/08/1995SE |
| K946307 | Cyrstalline L3 Multi-Use Hybrid CompositeEBF · Traditional | 01/26/1995SE |
| K940546 | Granitec Ionomer Resin CementEMA · Traditional | 04/29/1994SE |
| K936070 | Trend Set 2 PlusELW · Traditional | 02/04/1994SE |
| K935714 | Crystalline L3 Multi-Use Hybrid CompositeDYH · Traditional | 01/21/1994SE |
Questions and answers
When was Orthodontic Bracket Adhesive Resin Material cleared by the FDA?
Orthodontic Bracket Adhesive Resin Material (K914317) received a 510(k) decision of Substantially Equivalent on March 26, 1992, 182 days after the submission was received.
What is the product code of K914317?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.