Flexible Block
FDA 510(k) K213994 · Shandong Huge Dental Material Corporation
510(k) numberK213994
Submission
- Device name
- Flexible Block
- Applicant
- Shandong Huge Dental Material Corporation
Rizhao City, CN - Received
- December 21, 2021
- Decision date
- March 4, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260376 | Denture BaseEBI · Traditional | Shandong Huge Dental Material Corporation | 05/06/2026SE |
| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K260376 | Denture BaseEBI · Traditional | 05/06/2026SE |
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| K251252 | NOBILCAM IMPAK DiscMQC · Traditional | 08/01/2025SE |
| K220680 | Denture Base PolymersEBI · Traditional | 08/12/2022SE |
| K201684 | A-Silicone for Bite RegistrationELW · Traditional | 09/24/2020SE |
| K181747 | Orthodontic ApplianceNXC · Traditional | 04/18/2019SE |
| K160345 | Glass Ionomer CementEMA · Traditional | 03/03/2017SE |
| K161851 | Glass Ionomer Cement (Luting)EMA · Traditional | 10/31/2016SE |
Questions and answers
When was Flexible Block cleared by the FDA?
Flexible Block (K213994) received a 510(k) decision of Substantially Equivalent on March 4, 2022, 73 days after the submission was received.
What is the product code of K213994?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.