Tooth Shade Resin Material
FDA 510(k) K162323 · Liaoning Upcera Co., Ltd.
510(k) numberK162323
Submission
- Device name
- Tooth Shade Resin Material
- Applicant
- Liaoning Upcera Co., Ltd.
Benxi, CN - Received
- August 19, 2016
- Decision date
- January 12, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tooth Shade Resin Material cleared by the FDA?
Tooth Shade Resin Material (K162323) received a 510(k) decision of Substantially Equivalent on January 12, 2017, 146 days after the submission was received.
What is the product code of K162323?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.