G-Bond Plus
510(k) K082768
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082768 | Date21 Oct 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KLE
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
G-Bond Plus is a one-bottle, light-cured dental bonding agent designed for bonding light-cured composite resin to tooth structure. It falls under the category of dental agents, specifically resin-based bonding systems, and is intended to create a durable mechanical and chemical seal between restorative materials and dental tissues. The formulation incorporates Phosphoric Acid Ester Monomer and 4-MET adhesive technology to enhance adhesion to enamel and dentin, reducing void formation in shallow cavities.
This device is supplied as a single-component system, requiring activation via light curing. It is classified as a Class II medical device under FDA regulations (872.3200) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. G-Bond Plus is intended for use in dental settings, where it is applied to prepared tooth surfaces before composite resin placement. The product is not described as single-use or reusable in the regulatory data, and no specific sterility or MRI safety information is provided. The product code KLE and registration numbers are listed for identification purposes.
Other devices from Gc America Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the G-Bond Plus bonding agent used for?
G-Bond Plus is a resin-based bonding agent designed specifically for bonding light-cured composite resin to tooth structure. It creates a durable mechanical and chemical seal between restorative materials and dental tissues, helping to prevent void formation in shallow cavities. This ensures a stronger, more reliable bond during dental restorations.
How is the G-Bond Plus bonding agent supplied and activated?
G-Bond Plus is supplied as a single-component system, meaning it comes in one bottle. Unlike multi-step systems, it requires only activation via light curing to achieve its bonding properties. This simplifies the application process in clinical settings.
Is G-Bond Plus intended for single-use or reusable applications?
The regulatory data does not explicitly state whether G-Bond Plus is intended for single-use or reusable applications. However, dental bonding agents of this type are typically designed for single-use per patient to ensure sterility and prevent cross-contamination. Always follow manufacturer guidelines for proper usage.
What makes the adhesion of G-Bond Plus particularly effective?
G-Bond Plus incorporates Phosphoric Acid Ester Monomer and 4-MET adhesive technology, which enhances its ability to bond effectively to both enamel and dentin. This formulation helps reduce void formation in shallow cavities, improving the longevity and integrity of composite restorations.
What regulatory pathway was followed for G-Bond Plus?
G-Bond Plus received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a predicate device already on the market. The device is classified under FDA regulation number 872.3200 and falls under the product code KLE, indicating its classification as a dental agent.