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Sign in to claim this brandWhat DTS Digital Dental Lab makes
DTS Digital Dental Lab manufactures custom dental prosthetics, including ceramic and polymer dental bridges, metal-ceramic restorations, and orthodontic retainers. Their portfolio also covers complete and partial dentures for both upper and lower arches, as well as resin-based crown and bridge restorations.
These devices are classified under the FDA’s Class II regulatory category and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable dental device regulations in that jurisdiction.
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 DTS Digital Dental Lab manufacture?
DTS Digital Dental Lab specializes in custom dental prosthetics. Their portfolio includes ceramic and polymer dental bridges, metal-ceramic restorations, orthodontic retainers, and full or partial dentures for both upper and lower arches. These devices are designed to restore function and aesthetics in dental patients.
Where is DTS Digital Dental Lab based, and what jurisdiction governs its devices?
DTS Digital Dental Lab is based in the United States. Since their devices fall under dental prosthetics, they are subject to U.S. regulatory requirements, including classification under the FDA’s regulatory framework.
How are DTS Digital Dental Lab’s devices classified by the FDA?
DTS Digital Dental Lab’s devices are classified under the FDA’s Class II regulatory category. This classification applies to dental prosthetics like bridges, dentures, and retainers, which require special controls to ensure safety and effectiveness without the need for pre-market approval.
Are DTS Digital Dental Lab’s devices listed in any regulatory databases?
Yes, DTS Digital Dental Lab’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps track and identify their products in compliance with U.S. regulatory requirements for transparency and traceability.
What distinguishes DTS Digital Dental Lab’s dental prosthetics from others in the market?
DTS Digital Dental Lab focuses on custom dental prosthetics, including advanced materials like ceramic, polymer, and metal-ceramic composites. Their portfolio spans full and partial dentures, orthodontic retainers, and bridges, catering to precise patient needs while adhering to FDA Class II standards for dental restorations.
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
- 617176585
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dts, Dentures, Partial | REMOVABLE PARTIAL | FDA UDI | N | Active |
| Dts, Restoration, Porcelain | All-ceramic Crown/Bridge | FDA UDI | N | Active |
| Dts, Restoration, Porcelain-Fused | Porcelain Fused to | FDA UDI | N | Active |
| DTS, Prosthesis, orthodontic | Removable Orthodontic | FDA UDI | N | Active |
| Dts, Restoration, Resin, Crown And | TEMPORARY CROWN AND | FDA UDI | N | Active |
| Dts, Dentures, Full | IMMEDIATE DENTURE | FDA UDI | N | Active |
| Dts, Dentures, Full | FULL DENTURE | FDA UDI | N | Active |
| Dts, Dentures, Partial | DENTURES, PARTIAL | FDA UDI | N | Active |
| Dts, Restoration, Porcelain | All-ceramic Crown/Bridge | FDA UDI | N | Active |
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