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Sign in to claim this brandIncisive Technologies Pty, Ltd.
US
Last updated May 30, 2026
What Incisive Technologies Pty, Ltd. makes
Incisive Technologies Pty, Ltd. manufactures dental caries detecting stains designed to identify tooth decay in patients. The BlueCheck product line, including variants like BlueCheck Caries Detection & Monitoring, uses a visible stain to highlight areas of demineralization on teeth, aiding in early caries detection and monitoring during dental examinations.
The company’s dental caries detection devices fall under FDA Class II regulation and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. These products are intended for use in the United States, where they are subject to compliance with FDA requirements for diagnostic and monitoring devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Incisive Technologies Pty, Ltd. manufacture?
Incisive Technologies Pty, Ltd. specializes in dental caries detecting stains, specifically products like the BlueCheck line. These devices use a visible stain to identify demineralized areas on teeth, helping dental professionals detect and monitor early signs of tooth decay during examinations. The focus is on diagnostic tools for caries detection.
Where is Incisive Technologies Pty, Ltd. based, and what markets do its devices serve?
Incisive Technologies Pty, Ltd. is based in the United States. Its dental caries detection devices, such as the BlueCheck products, are designed for use in the U.S. market, where they must comply with FDA regulations for diagnostic and monitoring devices. The company’s products are tailored to support dental professionals in identifying and managing tooth decay.
Which regulatory registries or databases list Incisive Technologies Pty, Ltd.’s devices?
Incisive Technologies Pty, Ltd.’s dental caries detection devices, including the BlueCheck line, are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. regulatory requirements for Class II medical devices, which apply to their caries detection products.
How are Incisive Technologies Pty, Ltd.’s devices classified under U.S. regulations?
Incisive Technologies Pty, Ltd.’s dental caries detecting stains, such as the BlueCheck products, are classified as FDA Class II devices. This classification is based on their role in diagnosing dental caries, which requires special controls to ensure their safety and effectiveness. Class II designation means these devices undergo a 510(k) premarket notification process to demonstrate compliance with applicable regulations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 747210755
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BlueCheck | BN01AUS | FDA UDI | Class II | Active |
| BlueCheck | BN01BUS | FDA UDI | Class II | Active |
| BlueCheck™ Caries Detection & Monitoring | K222560 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Incisive Technologies Pty Ltd Ferntree Gully Victoria · AU FEI 3033588343