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Sign in to claim this brandDental Evolutions, Inc.
US
Last updated May 23, 2026
What Dental Evolutions, Inc. makes
Dental Evolutions, Inc. manufactures dental implant systems, including the Implanova brand, which are designed for osseointegrated tooth replacement in dental procedures. These systems are intended for use in the placement of dental implants within the jawbone to support prosthetic teeth.
The company’s implant systems are regulated under FDA classifications, with most devices falling into Class I and Class II categories. They are authorised through the FDA’s 510(k) and UDI programs, ensuring compliance with US medical device regulations. The manufacturer is based in 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 Dental Evolutions, Inc. primarily manufacture?
Dental Evolutions, Inc. specializes in dental implant systems, specifically focusing on osseointegrated solutions like the Implanova brand. These devices are designed to replace missing teeth by integrating with the jawbone to support dental prosthetics. The company’s portfolio is centered on this category, ensuring its products meet the needs of dental restoration procedures.
Where is Dental Evolutions, Inc. based, and how does that affect its regulatory standing?
Dental Evolutions, Inc. is headquartered in the United States. Since the company operates within the US market, its devices are subject to FDA regulations. The FDA’s 510(k) and UDI programs are key pathways for authorizing these products, ensuring compliance with US medical device standards. Being based in the US also means its devices are evaluated under the agency’s classification system, which includes Class I and Class II categories for dental implants.
Which regulatory registries or databases list Dental Evolutions, Inc.’s devices?
Dental Evolutions, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) system. The 510(k) pathway demonstrates that these products have been reviewed for substantial equivalence to a legally marketed predicate device, while the UDI system ensures traceability and identification of the devices in the market. These registries reflect the company’s compliance with US regulatory requirements.
How are Dental Evolutions, Inc.’s dental implant systems classified under FDA regulations?
Dental Evolutions, Inc.’s dental implant systems are primarily classified as Class I or Class II devices under FDA regulations. Class I devices generally pose minimal risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the complexity of the implant system and the potential risks involved in its use, as determined by the FDA.
Why do some of Dental Evolutions, Inc.’s dental implant systems fall under Class II classification?
The FDA assigns Class II classification to dental implant systems that, while not posing extreme risk, require valid scientific evidence to ensure their safety and performance. For example, implants that involve precise placement techniques, patient-specific customization, or potential risks like infection or improper integration with bone may fall into this category. Class II classification ensures additional scrutiny, such as post-market surveillance or special labeling requirements, to mitigate these risks.
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
- 065079164
Catalogue (93)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Implanova | ABSNM | FDA UDI | Class II | Active |
| Implanova | ABSWL | FDA UDI | Class II | Active |
| Implanova | TLAB | FDA UDI | Class II | Active |
| Implanova | AHTSS | FDA UDI | Class II | Active |
| Implanova | U20M | FDA UDI | Class II | Active |
| Implanova | IB4506 | FDA UDI | Class II | Active |
| Implanova | IB5512 | FDA UDI | Class II | Active |
| Implanova | AB155P | FDA UDI | Class II | Active |
| Implanova | IB4510 | FDA UDI | Class II | Active |
| Implanova | AHBSPM | FDA UDI | Class II | Active |
| Implanova | IB6506 | FDA UDI | Class II | Active |
| Implanova | CAWS | FDA UDI | Class II | Active |
| Implanova | RAB | FDA UDI | Class II | Active |
| Implanova | AHBSPS | FDA UDI | Class II | Active |
| Implanova | IB7508 | FDA UDI | Class II | Active |
| Implanova | AHBWPS | FDA UDI | Class II | Active |
| Implanova | CANS | FDA UDI | Class II | Active |
| Implanova | IB8510 | FDA UDI | Class II | Active |
| Implanova | IB5506 | FDA UDI | Class II | Active |
| Implanova | U15M | FDA UDI | Class II | Active |
| Implanova | U7.5M | FDA UDI | Class II | Active |
| Implanova | U7.5S | FDA UDI | Class II | Active |
| Implanova | AHBSPL | FDA UDI | Class II | Active |
| Implanova | ABSSM | FDA UDI | Class II | Active |
| Implanova | AHBNPL | FDA UDI | Class II | Active |
| Implanova | IB6510 | FDA UDI | Class II | Active |
| Implanova | IB4508 | FDA UDI | Class II | Active |
| Implanova | AHBNPS | FDA UDI | Class II | Active |
| Implanova | ABSSL | FDA UDI | Class II | Active |
| Implanova | IB6508 | FDA UDI | Class II | Active |
| Implanova | IB7506 | FDA UDI | Class II | Active |
| Implanova | IT4014 | FDA UDI | Class II | Active |
| Implanova | CANL | FDA UDI | Class II | Active |
| Implanova | CAWL | FDA UDI | Class II | Active |
| Implanova | IB4512 | FDA UDI | Class II | Active |
| Implanova | CANM | FDA UDI | Class II | Active |
| Implanova | ABNNP | FDA UDI | Class II | Active |
| Implanova | AIMPRC | FDA UDI | Class I | Active |
| Implanova | FGCK | FDA UDI | Class II | Active |
| Implanova | DHM | FDA UDI | Class I | Active |
| Implanova | U15L | FDA UDI | Class II | Active |
| Implanova | K150040 | FDA 510(k) | Class II | Active |
| Implanova | K210523 | FDA 510(k) | Class II | Active |
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