Bosworth Super Bond Dental Adhesive
FDA 510(k) K842448 · Harry J. Bosworth Co.
510(k) numberK842448
Submission
- Device name
- Bosworth Super Bond Dental Adhesive
- Applicant
- Harry J. Bosworth Co.
Mchenry, IL, US - Received
- June 22, 1984
- Decision date
- September 27, 1984
- 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 |
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| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K103585 | Bosworth Aegis Liner & Restorative Material W/AcpEMA · Traditional | 03/04/2011SE |
| K100731 | Bosworth Air PolisherEFB · Traditional | 12/03/2010SE |
| K061611 | Bosworth Dentin ResinKLE · Traditional | 09/11/2006SE |
| K051224 | Bosworth SealEBC · Traditional | 07/28/2005SE |
| K043170 | Bosworth BondKLE · Traditional | 02/25/2005SE |
| K040548 | Aegis Ortho Light-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K040547 | Aegis Ortho Dual-Cured Orthodontic AdhesiveDYH · Traditional | 03/19/2004SE |
| K033751 | Aegis Pit & Fissure Sealant with AcpEBC · Traditional | 02/05/2004SE |
| K031439 | Alginate Impression Material III (Fast & Regular)ELW · Traditional | 10/02/2003SE |
| K031811 | Pit & Fissure Sealant with FluorideEBC · Traditional | 09/04/2003SE |
Questions and answers
When was Bosworth Super Bond Dental Adhesive cleared by the FDA?
Bosworth Super Bond Dental Adhesive (K842448) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 97 days after the submission was received.
What is the product code of K842448?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.