RM Bond, Model J032
FDA 510(k) K072830 · Pentron Clinical Technologies
510(k) numberK072830
Submission
- Device name
- RM Bond, Model J032
- Applicant
- Pentron Clinical Technologies
Wallingford, CT, US - Received
- October 3, 2007
- Decision date
- December 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K091512 | Build-It Light CureEBF · Traditional | 10/30/2009SE |
| K081887 | Lute-It II Veneer Cement, Model NO6EMA · Traditional | 08/29/2008SE |
| K072480 | Generation 8 Se AdhesiveKLE · Traditional | 11/21/2007SE |
| K072545 | Artiste Se Flowable Composite, Model N280EBF · Traditional | 10/26/2007SE |
| K071500 | Nano-Bond II Adhesive SystemKLE · Traditional | 08/10/2007SE |
| K060889 | Se Epiphany Root Canal Sealant, Model N59SEKIF · Traditional | 10/27/2006SE |
| K060698 | Cement-It All Purpose, Model N97EMA · Traditional | 05/10/2006SE |
| K052106 | Simile FlowEBF · Traditional | 10/31/2005SE |
| K052349 | Avante LED Curing Unit, Model N44EBZ · Traditional | 10/21/2005SE |
| K023818 | Fiberfill AgpKIF · Traditional | 04/03/2003SE |
Questions and answers
When was RM Bond, Model J032 cleared by the FDA?
RM Bond, Model J032 (K072830) received a 510(k) decision of Substantially Equivalent on December 4, 2007, 62 days after the submission was received.
What is the product code of K072830?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.