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Sign in to claim this brandLuxCreo, Inc.
US
Last updated May 30, 2026
What LuxCreo, Inc. makes
LuxCreo, Inc. produces thermoplastic and resin materials for dental appliance fabrication, including systems for orthodontic progressive aligners and space maintainers. Their portfolio includes clear aligner resins and night guard resins designed for dental applications, as well as complete clear aligner systems for orthodontic treatment.
The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U) devices. These products are listed under the FDA’s 510(k) and Unique Device Identifier (UDI) programs, reflecting their compliance with U.S. medical device regulations.
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 LuxCreo, Inc. manufacture?
LuxCreo, Inc. specializes in materials and systems used for dental appliance fabrication. Their portfolio includes thermoplastic and resin materials for dental applications, such as clear aligner resins, night guard resins, and complete clear aligner systems for orthodontic treatment. These devices are designed to support orthodontic procedures like progressive aligner therapy and space maintenance.
Where is LuxCreo, Inc. based?
LuxCreo, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance with U.S. medical device standards, including those enforced by the FDA.
Which regulatory registries or databases list LuxCreo, Inc.’s devices?
LuxCreo, Inc.’s devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) programs. These registries ensure traceability and compliance with U.S. medical device regulations, helping healthcare providers and regulators verify the devices’ classification and authorization status.
How are LuxCreo, Inc.’s devices classified under FDA regulations?
LuxCreo, Inc.’s devices fall under FDA classifications of Class I, Class II, and Unclassified (U). The classification depends on factors like risk level and intended use—for example, dental resins and aligners may carry different risk profiles, influencing their regulatory pathway. Class I devices are generally low-risk, while Class II requires special controls, and Unclassified devices undergo individual evaluation.
What distinguishes LuxCreo’s dental appliance materials from other similar products?
LuxCreo’s dental appliance materials are tailored for specific orthodontic applications, such as clear aligner fabrication and night guard production. Their thermoplastic and resin formulations are designed to meet the precision and durability requirements of dental treatments, ensuring compatibility with orthodontic systems like progressive aligners and space maintainers. The company’s focus on these specialized materials differentiates their offerings in the dental appliance market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- luxcreo.ai
- —
- —
- [email protected]
- Phone
- +8613738495712
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117470150
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LuxCreo Dental Clear Aligner Resin | 0.5kg/Bottle | FDA UDI | Class I | Active |
| LuxCreo Dental Night Guard Resin | 0.5kg/Bottle | FDA UDI | Class I | Active |
| LuxCreo Clear Aligner System | DCA-TB | FDA UDI | Class II | Active |
| LuxCreo Clear Aligner System | DCA-TC | FDA UDI | Class II | Active |
| LuxCreo Dental Night Guard Resin | 1kg/Bottle | FDA UDI | Class I | Active |
| LuxCreo Clear Aligner System | DCA-TB | FDA UDI | Class II | Active |
| LuxCreo DentalNight Guard Resin | 5kg/Bottle | FDA UDI | U | Active |
| LuxCreo DentalNight Guard Resin | 1kg/Bottle | FDA UDI | U | Active |
| LuxCreo Dental Night Guard Resin | 5kg/Bottle | FDA UDI | Class I | Active |
| LuxCreo DentalNight Guard Resin | 0.5kg/Bottle | FDA UDI | U | Active |
| LuxCreo Dental Clear Aligner Resin | 1kg/Bottle | FDA UDI | Class I | Active |
| LuxCreo Clear Aligner System | DCA-TC | FDA UDI | Class II | Active |
| LuxCreo Dental Night Guard Resin | K230592 | FDA 510(k) | U | Active |
| LuxCreo Flexible Partial Denture Resin | K253365 | FDA 510(k) | Class II | Active |
| LuxCreo Clear Aligner System | K212680 | FDA 510(k) | Class II | Active |
| LuxCreo Clear Aligner System | K250343 | FDA 510(k) | Class II | Active |
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