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Sign in to claim this brandWhat DENTAL MANUFACTURING SPA makes
Dental Manufacturing SPA produces resin artificial teeth, including variants such as ACRY PLUS, ACRY SMART, and ACRY PLUS V., designed for dental prosthetics and restorative applications. These products are intended for use in dental laboratories to fabricate crowns, bridges, and partial dentures. The portfolio includes both traditional and digital-enabled resin formulations for precision fitting and durability.
The company’s resin artificial teeth are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use within the United States, adhering to applicable regulatory standards for dental restorative materials. The manufacturer is based in the US.
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 Dental Manufacturing SPA primarily manufacture?
Dental Manufacturing SPA specializes in resin artificial teeth, which are used in dental prosthetics. These products are designed for dental laboratories to create crowns, bridges, and partial dentures. The company’s portfolio includes traditional resin formulations like ACRY PLUS and ACRY SMART, as well as digital-enabled variants such as ACRY SMART DIGITAL, catering to modern precision and durability needs in restorative dentistry.
Where is Dental Manufacturing SPA based, and what region does it serve?
Dental Manufacturing SPA is based in the United States. Its resin artificial teeth are intended for use within the US market, adhering to applicable regulatory standards for dental restorative materials. The company’s products are designed to meet the needs of dental professionals and laboratories operating in this region.
How are Dental Manufacturing SPA’s devices classified under regulatory standards?
Dental Manufacturing SPA’s resin artificial teeth are classified as Class II medical devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as resin-based dental restorations that require validation of performance and biocompatibility.
Are Dental Manufacturing SPA’s devices listed in any regulatory registries?
Yes, Dental Manufacturing SPA’s resin artificial teeth are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their distribution and use, ensuring transparency and regulatory compliance for devices like these, which are intended for dental prosthetics and restorative applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 435782248
Catalogue (52)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acry Smart Digital | ACRY SMART DIGITAL 8 LOWER | FDA UDI | Class II | Active |
| Acry Smart | ACRY SMART 6 LOWER | FDA UDI | Class II | Active |
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