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Sign in to claim this brandDenplus Inc
US
Last updated May 23, 2026
What Denplus Inc makes
Denplus Inc manufactures dental materials used in orthodontic and restorative procedures, including resin-based fabrication materials for dental appliances, impression tray materials for capturing oral impressions, and base plates for bite registration and wax rims. Their product line also includes repair materials for dental devices and specialized waxes for bite registration applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised through the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. These materials are intended for use in dental laboratories and clinical settings within the United States.
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 Denplus Inc manufacture?
Denplus Inc specializes in dental materials used primarily in orthodontic and restorative procedures. Their product line includes resin-based fabrication materials for dental appliances, impression tray materials for capturing oral impressions, dental base plates for bite registration, and specialized waxes like bite registration rim wax. These materials are designed for use in dental laboratories and clinical settings.
Where is Denplus Inc based, and what is its primary focus?
Denplus Inc is based in the United States. The company focuses on developing dental materials that support orthodontic and restorative treatments, such as appliances, impression trays, and bite registration aids. Their products are tailored for dental professionals working in laboratories or clinical environments.
Which regulatory registries list Denplus Inc’s devices?
Denplus Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. Additionally, several of their products have been authorised through the FDA’s 510(k) premarket notification process, which is a pathway for demonstrating substantial equivalence to a legally marketed predicate device.
How are Denplus Inc’s devices classified under FDA regulations?
Denplus Inc’s devices are classified under two categories by the FDA: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific use and potential risk associated with each product.
What is the intended use of Denplus Inc’s dental materials?
Denplus Inc’s dental materials are intended for use in dental laboratories and clinical settings to support procedures like orthodontic appliance fabrication, capturing oral impressions, and bite registration. These materials are designed to aid dental professionals in creating custom-fit devices, repairing existing appliances, and ensuring accurate impressions for restorative treatments.
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
- 202016064
Catalogue (182)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dp-Repair | 1071301 | FDA UDI | Class II | Active |
| Impact-Plus | 1011105 | FDA UDI | Class II | Active |
| Dp97 | 1001102 | FDA UDI | Class II | Active |
| Dp-Repair | 1061102 | FDA UDI | Class II | Active |
| Impact-20 | 1031302 | FDA UDI | Class II | Active |
| Dp-Repair | 1071304 | FDA UDI | Class II | Active |
| Impact-20 | 1031204 | FDA UDI | Class II | Active |
| Dp-Repair | 1071201 | FDA UDI | Class II | Active |
| Pour-Plus | 1152200 | FDA UDI | Class II | Active |
| Dp-Repair | 1071102 | FDA UDI | Class II | Active |
| Dp-Repair | 1061201 | FDA UDI | Class II | Active |
| Impact-20 | 1031203 | FDA UDI | Class II | Active |
| Impact-Plus | 1011204 | FDA UDI | Class II | Active |
| Dp-Repair | 1071307 | FDA UDI | Class II | Active |
| Dp-Repair | 1061100 | FDA UDI | Class II | Active |
| Photo-Base | 3051101 | FDA UDI | Class I | Active |
| High-Wave | 1141216 | FDA UDI | Class II | Active |
| Impact-Plus | 1011201 | FDA UDI | Class II | Active |
| Pour-Plus | 1151107 | FDA UDI | Class II | Active |
| Pour-Plus | 1151105 | FDA UDI | Class II | Active |
| Dp-Repair | 1071302 | FDA UDI | Class II | Active |
| Dp-Repair | 1061301 | FDA UDI | Class II | Active |
| Impact-Plus | 1011317 | FDA UDI | Class II | Active |
| Dp97 | 1001309 | FDA UDI | Class II | Active |
| Dp-Hc | 1012200 | FDA UDI | Class II | Active |
| Impact-Plus | 1011205 | FDA UDI | Class II | Active |
| Pour-Plus | 1152100 | FDA UDI | Class II | Active |
| Impact-Plus | 1011309 | FDA UDI | Class II | Active |
| Premium Tray | 1121212 | FDA UDI | Class I | Active |
| Impact-Plus | 1011116 | FDA UDI | Class II | Active |
| Impact-20 | 1030104 | FDA UDI | Class II | Active |
| Dp-Repair | 1061105 | FDA UDI | Class II | Active |
| Premium Tray | 1121115 | FDA UDI | Class I | Active |
| Impact-Plus | 1011316 | FDA UDI | Class II | Active |
| Impact-20 | 1031101 | FDA UDI | Class II | Active |
| Impact-Plus | 1011304 | FDA UDI | Class II | Active |
| Impact-20 | 1031103 | FDA UDI | Class II | Active |
| Impact-Plus | 1011303 | FDA UDI | Class II | Active |
| Impact-Plus | 1011117 | FDA UDI | Class II | Active |
| Impact-Plus | 1011102 | FDA UDI | Class II | Active |
| Dp-Repair | 1061304 | FDA UDI | Class II | Active |
| Impact-20 | 1031307 | FDA UDI | Class II | Active |
| BasePlate Wax | 3001102 | FDA UDI | Class I | Active |
| Impact-Plus | 1011302 | FDA UDI | Class II | Active |
| Impact-Plus | 1011202 | FDA UDI | Class II | Active |
| Pour-Plus | 1151300 | FDA UDI | Class II | Active |
| 20 Minutes | 1032200 | FDA UDI | Class II | Active |
| Impact-Plus | 1011103 | FDA UDI | Class II | Active |
| Dp97 | 1001302 | FDA UDI | Class II | Active |
| Pour-Plus | 1151207 | FDA UDI | Class II | Active |
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