Any-Etch
FDA 510(k) K260485 · Mediclus Co., Ltd.
510(k) numberK260485
Submission
- Device name
- Any-Etch
- Applicant
- Mediclus Co., Ltd.
Cheongju-Si, KR - Received
- February 13, 2026
- Decision date
- May 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| 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 |
|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | 08/21/2026SE |
| K254201 | Any-CemEMA · Traditional | 08/13/2026SE |
| K261728 | One-Fil LCEJK · Traditional | 07/21/2026SE |
| K260819 | Any-Com SealEBC · Traditional | 05/01/2026SE |
| K253797 | One-StopMVL · Traditional | 02/27/2026SE |
| K253167 | Any-PasteKIF · Traditional | 01/12/2026SE |
| K252465 | Any-CoreEBF · Traditional | 12/05/2025SE |
| K251884 | One-Fil Putty InjectableKIF · Special | 08/22/2025SE |
| K251283 | Once-Fil FlowEBF · Traditional | 06/06/2025SE |
| K250823 | Any-Com FlowEBF · Special | 04/14/2025SE |
Questions and answers
When was Any-Etch cleared by the FDA?
Any-Etch (K260485) received a 510(k) decision of Substantially Equivalent on May 14, 2026, 90 days after the submission was received.
What is the product code of K260485?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.