Porcelain Etch Gel
FDA 510(k) K260430 · Belport Company, Inc., Gingi-Pak
510(k) numberK260430
Submission
- Device name
- Porcelain Etch Gel
- Applicant
- Belport Company, Inc., Gingi-Pak
Camarillo, CA, US - Received
- February 10, 2026
- Decision date
- April 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| 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 |
| 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 |
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| K251775 | RODIN CementEMA · Traditional | 09/02/2025SE |
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| K240688 | RODIN Titan 3D ResinEBI · Traditional | 06/20/2024SE |
| K231060 | ProMin Dental Desensitizing GelLBH · Traditional | 06/13/2024SE |
| K231793 | RODIN 3D Resin SPLINT, Hard/FlexMQC · Traditional | 03/26/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | 03/27/2023SE |
| K211420 | Stasis GelMVL · Traditional | 03/14/2022SE |
| K211419 | Gingi-Aid GelMVL · Traditional | 01/10/2022SE |
| K200462 | EtchPro Etching GelKLE · Traditional | 09/02/2020SE |
Questions and answers
When was Porcelain Etch Gel cleared by the FDA?
Porcelain Etch Gel (K260430) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 59 days after the submission was received.
What is the product code of K260430?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.