G-Bond Universal
FDA 510(k) K251124 · GC America, Inc.
510(k) numberK251124
Submission
- Device name
- G-Bond Universal
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- April 11, 2025
- Decision date
- October 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
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| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
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| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | Spident Co., Ltd. | 11/01/2024SE |
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| K254109 | G-Cem UniversalEMA · Traditional | 05/18/2026SE |
| K250953 | Equia LC OneEMA · Traditional | 09/19/2025SE |
| K251946 | G aenial Universal Injectable IIEBF · Traditional | 08/29/2025SE |
| K200798 | G-Cem OneEMA · Traditional | 11/24/2020SE |
| K200682 | BZF-29KLE · Traditional | 10/02/2020SE |
| K192597 | Cytrans GranulesLYC · Abbreviated | 08/17/2020SE |
| K193113 | GC Temp PrintEBG · Traditional | 07/09/2020SE |
Questions and answers
When was G-Bond Universal cleared by the FDA?
G-Bond Universal (K251124) received a 510(k) decision of Substantially Equivalent on October 2, 2025, 174 days after the submission was received.
What is the product code of K251124?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.