Enamel Coating Resin
FDA 510(k) K230455 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK230455
Submission
- Device name
- Enamel Coating Resin
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao City, CN - Received
- February 21, 2023
- Decision date
- July 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260819 | Any-Com SealEBC · Traditional | Mediclus Co., Ltd. | 05/01/2026SE |
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| K190339 | Helioseal F PlusEBC · Abbreviated | Ivoclar Vivadent, AG | 07/29/2019SE |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCPEBC · Traditional | Pulpdent Corporation | 01/05/2018SE |
| K171330 | Nanova SealantEBC · Traditional | Nanova Biomaterials, Inc. | 09/08/2017SE |
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| K161580 | Premier SealantEBC · Traditional | Premier Dental Company Products | 10/18/2016SE |
| K141717 | Pacseal Pit & Fissure SealantEBC · Traditional | Pac-Dent International, Inc. | 03/09/2015SE |
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| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | 12/20/2024SE |
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| K241204 | TopCEM-Veneer Light Cure Veneer CementEMA · Traditional | 06/28/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | 12/22/2023SE |
| K221510 | TrusFIL-Flow Flowable Composite RestorativeEBF · Traditional | 10/12/2022SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | 09/12/2022SE |
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Questions and answers
When was Enamel Coating Resin cleared by the FDA?
Enamel Coating Resin (K230455) received a 510(k) decision of Substantially Equivalent on July 25, 2023, 154 days after the submission was received.
What is the product code of K230455?
The FDA product code is EBC – Sealant, Pit And Fissure, And Conditioner, a Class II (moderate risk) device regulated under 21 CFR 872.3765.