K-Bond Universal
FDA 510(k) K241445 · Spident Co., Ltd.
510(k) numberK241445
Submission
- Device name
- K-Bond Universal
- Applicant
- Spident Co., Ltd.
Incheon, KR - Received
- May 22, 2024
- Decision date
- July 22, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLE
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|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| 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 |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262050 | Vioseal XKIF · Traditional | 09/11/2026SE |
| K261129 | OrthoFitDYH · Traditional | 07/02/2026SE |
| K250566 | EsCem RMGIEMA · Traditional | 06/20/2025SE |
| K250317 | EsFlow PLUSEBF · Traditional | 05/30/2025SE |
| K242702 | VioSealKIF · Traditional | 11/07/2024SE |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | 11/01/2024SE |
| K231523 | EsCom250EBF · Traditional | 07/24/2023SE |
| K214076 | EsCemEMA · Traditional | 12/19/2022SE |
| K214071 | Hexa-TempEBG · Traditional | 03/10/2022SE |
| K161774 | i-SilELW · Traditional | 09/30/2016SE |
Questions and answers
When was K-Bond Universal cleared by the FDA?
K-Bond Universal (K241445) received a 510(k) decision of Substantially Equivalent on July 22, 2024, 61 days after the submission was received.
What is the product code of K241445?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.