Phosphoric Acid Etching Gel
FDA 510(k) K221450 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK221450
Submission
- Device name
- Phosphoric Acid Etching Gel
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao City, CN - Received
- May 18, 2022
- Decision date
- September 12, 2022
- 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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| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| 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 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, 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 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · 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 |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | 10/06/2021SE |
Questions and answers
When was Phosphoric Acid Etching Gel cleared by the FDA?
Phosphoric Acid Etching Gel (K221450) received a 510(k) decision of Substantially Equivalent on September 12, 2022, 117 days after the submission was received.
What is the product code of K221450?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.