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jet bite jet blue bite fast jet blue bite superfast
Dent4You Ag
Summary: Jet Blue Bite Fast is a dental impression material used for bite registration. It is typically used by dental professionals in various procedures to ensure accurate occlusal records.
FDA Clearance Information
Pathway
510K
Number
K250969 ↗
Decision Date
June 27, 2025
Product Code
ELW
Device Class
Class 2
Evidence
0 studies
The Jet Blue Bite Fast, manufactured by Dent4You Ag, received FDA 510k clearance (K250969) on June 27, 2025. It is classified as a Class 2 device under product code ELW.
What It Is
Jet Blue Bite Fast is an addition silicone material designed for dental bite registration. It is known for its quick setting time and high elasticity, making it ideal for capturing accurate occlusal relationships. This material is used to create precise dental impressions, which are critical for the fabrication of dental restorations and appliances.
Clinical Applications
Jet Blue Bite Fast is commonly used in dental practices during procedures that require accurate bite registration, such as the creation of crowns, bridges, and dentures. It is particularly useful in prosthodontics and orthodontics, where precise occlusal records are essential. The material is suitable for use in both adult and pediatric populations.
Indications for Use
The FDA indications for Jet Blue Bite Fast focus on its use in capturing occlusal relationships in dental patients. It is intended for use in patients requiring dental restorations where accurate bite registration is necessary.
Practical Considerations
Jet Blue Bite Fast is available in various viscosities to accommodate different clinical needs. It is compatible with most dental impression trays and can be used with standard dental impression techniques. The material sets quickly, allowing for efficient workflow in busy dental practices.
Related Literature
The linked study evaluated the elastic properties of thirteen silicone interocclusal recording materials, including Jet Blue Bite Fast. The study found that Jet Blue Bite Fast exhibited favorable elasticity and mechanical properties compared to other materials tested. However, the study was limited by its in vitro design and did not assess clinical outcomes directly.
Frequently Asked Questions
What is Jet Blue Bite Fast used for?
Jet Blue Bite Fast is used for dental bite registration to capture accurate occlusal relationships.
What specialties typically use this device?
Prosthodontists and orthodontists commonly use this device for procedures requiring precise bite registration.
What are the FDA-cleared indications?
The device is indicated for capturing occlusal relationships in dental patients requiring restorations.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.