HF-Etchant Hydrofluoric Acid Etching Gel
FDA 510(k) K242530 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK242530
Submission
- Device name
- HF-Etchant Hydrofluoric Acid Etching Gel
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao, CN - Received
- August 26, 2024
- Decision date
- December 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
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| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | Spident Co., Ltd. | 11/01/2024SE |
More from Spident Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | 12/12/2025SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | 06/23/2025SE |
| K242572 | TopCEM-Try in Veneer Try-in GelEBF · Traditional | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | 11/08/2024SE |
| K241204 | TopCEM-Veneer Light Cure Veneer CementEMA · Traditional | 06/28/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | 12/22/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | 07/25/2023SE |
| K221510 | TrusFIL-Flow Flowable Composite RestorativeEBF · Traditional | 10/12/2022SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | 09/12/2022SE |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | 10/06/2021SE |
Questions and answers
When was HF-Etchant Hydrofluoric Acid Etching Gel cleared by the FDA?
HF-Etchant Hydrofluoric Acid Etching Gel (K242530) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 116 days after the submission was received.
What is the product code of K242530?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.