Tokuyama Universal Bond
FDA 510(k) K171226 · Tokuyama Dental Corporation
510(k) numberK171226
Submission
- Device name
- Tokuyama Universal Bond
- Applicant
- Tokuyama Dental Corporation
Tokyo, JP - Received
- April 26, 2017
- Decision date
- November 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
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| K203760 | Tokuyama Universal Bond IIKLE · Traditional | 05/25/2021SE |
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| K193537 | Omnichroma FlowEBF · Traditional | 08/19/2020SE |
| K190940 | Tokuyama Rebase IIIEBI · Traditional | 10/04/2019SE |
| K180613 | Estelite Universal FlowEBF · Traditional | 07/12/2018SE |
| K173275 | OmnichromaEBF · Traditional | 02/27/2018SE |
| K170549 | Tokuyama CuregraceEBI · Traditional | 07/05/2017SE |
| K161353 | ESTELITE BULK FILL FlowEBF · Traditional | 04/03/2017SE |
| K150727 | EstecemEMA · Traditional | 06/17/2015SE |
| K112445 | Sofreliner Tough SEBI · Traditional | 10/28/2011SE |
Questions and answers
When was Tokuyama Universal Bond cleared by the FDA?
Tokuyama Universal Bond (K171226) received a 510(k) decision of Substantially Equivalent on November 28, 2017, 216 days after the submission was received.
What is the product code of K171226?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.