Glass Ionomer Cement (Luting)
FDA 510(k) K161851 · Shandong Huge Dental Material Corporation
510(k) numberK161851
Submission
- Device name
- Glass Ionomer Cement (Luting)
- Applicant
- Shandong Huge Dental Material Corporation
Rizhao City, CN - Received
- July 6, 2016
- Decision date
- October 31, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K201684 | A-Silicone for Bite RegistrationELW · Traditional | 09/24/2020SE |
| K181747 | Orthodontic ApplianceNXC · Traditional | 04/18/2019SE |
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Questions and answers
When was Glass Ionomer Cement (Luting) cleared by the FDA?
Glass Ionomer Cement (Luting) (K161851) received a 510(k) decision of Substantially Equivalent on October 31, 2016, 117 days after the submission was received.
What is the product code of K161851?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.