Tokuyama Shield Force
FDA 510(k) K100172 · Tokuyama Dental Corporation
510(k) numberK100172
Submission
- Device name
- Tokuyama Shield Force
- Applicant
- Tokuyama Dental Corporation
Washington, DC, US - Received
- January 21, 2010
- Decision date
- October 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K203760 | Tokuyama Universal Bond IIKLE · Traditional | 05/25/2021SE |
| K203598 | Omnichroma Flow BulkEBF · Traditional | 02/03/2021SE |
| 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 |
| K171226 | Tokuyama Universal BondKLE · Traditional | 11/28/2017SE |
| K170549 | Tokuyama CuregraceEBI · Traditional | 07/05/2017SE |
| K161353 | ESTELITE BULK FILL FlowEBF · Traditional | 04/03/2017SE |
| K150727 | EstecemEMA · Traditional | 06/17/2015SE |
Questions and answers
When was Tokuyama Shield Force cleared by the FDA?
Tokuyama Shield Force (K100172) received a 510(k) decision of Substantially Equivalent on October 21, 2010, 273 days after the submission was received.
What is the product code of K100172?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.