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Sign in to claim this brandSPIRALTECH SUPERIOR DENTAL IMPLANTS, INC.
US
Last updated May 24, 2026
What SPIRALTECH SUPERIOR DENTAL IMPLANTS, INC. makes
The company manufactures screw-endosteal dental implants designed for two-piece applications, including temporary preformed suprastructures intended for reuse. It also produces collapsible, attendant-driven wheelchairs with rear-wheel operation, alongside healing abutments for dental implants. These products are used in oral rehabilitation and mobility assistance.
The portfolio includes Class II medical devices, regulated under FDA pathways such as the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These devices are listed in the United States, where the manufacturer is based.
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 SpiralTech Superior Dental Implants, Inc. primarily manufacture?
SpiralTech Superior Dental Implants, Inc. specializes in screw-endosteal dental implants designed for two-piece applications, meaning they consist of an implant placed into the jawbone and an abutment or suprastructure attached later. Their portfolio also includes temporary, preformed dental implant suprastructures intended for reuse, as well as collapsible, attendant-driven wheelchairs operated via rear wheels. These devices are engineered for oral rehabilitation and mobility assistance.
Where is SpiralTech Superior Dental Implants, Inc. based, and which regulatory registries list its devices?
The company is based in the United States. Its devices are listed in the FDA’s premarket notification (510(k)) registry and the Unique Device Identifier (UDI) system, reflecting their classification as Class II medical devices under U.S. regulations. These registries ensure compliance and traceability for devices authorized for use in the U.S. market.
How are the devices manufactured by SpiralTech Superior Dental Implants, Inc. classified under U.S. regulations?
All devices produced by SpiralTech Superior Dental Implants, Inc. fall under Class II classification in the U.S., which means they pose moderate risk and require premarket notification (510(k)) clearance or other regulatory pathways to demonstrate substantial equivalence to a legally marketed predicate device. This classification ensures additional scrutiny to validate safety and performance before authorization.
What is the purpose of the temporary dental implant suprastructures listed by the company?
The temporary preformed dental implant suprastructures manufactured by SpiralTech are designed as reusable components for two-piece dental implant systems. They serve as interim restorations or frameworks during the healing phase after implant placement, providing stability and functionality while the final restoration is fabricated. Their modular, reusable nature supports clinical flexibility and cost efficiency.
Why are the company’s devices required to use a Unique Device Identifier (UDI) under FDA regulations?
The FDA mandates UDIs for Class II devices like those produced by SpiralTech to improve tracking, reduce medical errors, and enhance post-market surveillance. A UDI ensures each device has a unique, machine-readable identifier that links it to critical information like specifications, manufacturing details, and regulatory status. This system supports transparency in the supply chain and helps healthcare providers verify device authenticity and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spiraltech.com
- —
- —
- [email protected]
- Phone
- +13124407777
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 086863437
Catalogue (298)
Page 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esi | ESIC43008A | FDA UDI | Class II | Active |
| Healing Abutment | HAH383 | FDA UDI | Class II | Active |
| Esi | ESI43008A | FDA UDI | Class II | Active |
| Esi | ESIC43015A | FDA UDI | Class II | Active |
| Esi | ESI60011R | FDA UDI | Class II | Active |
| Premium | PR35011A | FDA UDI | Class II | Active |
| Ultimate | ULC50010A | FDA UDI | Class II | Active |
| Premium | PRC50010A | FDA UDI | Class II | Active |
| Healing Abutment | HACNP453 | FDA UDI | Class II | Active |
| Esi | ESIC43011A | FDA UDI | Class II | Active |
| Ultimate | UL43011R | FDA UDI | Class II | Active |
| Premium | PR43015R | FDA UDI | Class II | Active |
| Premium | PRC60011A | FDA UDI | Class II | Active |
| Ultimate | UL35015R | FDA UDI | Class II | Active |
| Ultimate | UL35011R | FDA UDI | Class II | Active |
| Premium | PR35011R | FDA UDI | Class II | Active |
| Premium | PR50008R | FDA UDI | Class II | Active |
| Premium | PR60013A | FDA UDI | Class II | Active |
| Ultimate | UL60011A | FDA UDI | Class II | Active |
| Premium | PRC50008A | FDA UDI | Class II | Active |
| Premium | PRC60008A | FDA UDI | Class II | Active |
| Esi | ESI60015A | FDA UDI | Class II | Active |
| Healing Abutment | HACNP456 | FDA UDI | Class II | Active |
| Premium | PR60006A | FDA UDI | Class II | Active |
| Ultimate | ULC43008R | FDA UDI | Class II | Active |
| Premium | PRC50011A | FDA UDI | Class II | Active |
| Esi | ESIC30013R | FDA UDI | Class II | Active |
| Ultimate | ULC30013A | FDA UDI | Class II | Active |
| Premium | PRC50015R | FDA UDI | Class II | Active |
| Ultimate | ULC60008A | FDA UDI | Class II | Active |
| Esi | ESIC60013R | FDA UDI | Class II | Active |
| Esi | ESIC43011R | FDA UDI | Class II | Active |
| Esi | ESI35008A | FDA UDI | Class II | Active |
| Premium | PR43006R | FDA UDI | Class II | Active |
| Esi | ESI35010A | FDA UDI | Class II | Active |
| Healing Abutment | HACRP386 | FDA UDI | Class II | Active |
| Esi | ESIC30015A | FDA UDI | Class II | Active |
| Healing Abutment | HAH606 | FDA UDI | Class II | Active |
| Esi | ESIC30010R | FDA UDI | Class II | Active |
| Esi | ESI60015R | FDA UDI | Class II | Active |
| Esi | ESI60013R | FDA UDI | Class II | Active |
| Ultimate | UL43013R | FDA UDI | Class II | Active |
| Ultimate | UL43008A | FDA UDI | Class II | Active |
| Esi | ESI43008R | FDA UDI | Class II | Active |
| Ultimate | UL43010A | FDA UDI | Class II | Active |
| Premium | PR43011R | FDA UDI | Class II | Active |
| Esi | ESI35011R | FDA UDI | Class II | Active |
| Esi | ESIC35013R | FDA UDI | Class II | Active |
| Healing Abutment | HACRP384 | FDA UDI | Class II | Active |
| Esi | ESI43010A | FDA UDI | Class II | Active |
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