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APOLLO IMPLANT COMPONENTS SP Z O O

US

Last updated May 30, 2026

Part of APOLLO IMPLANT COMPONENTS Sp. z o.o.

What APOLLO IMPLANT COMPONENTS SP Z O O makes

Apollo Implant Components produces single-use dental implant abutment analogs designed for intraoral scanning. These adapters include variants such as single-wing and double-wing designs, as well as complete scanning kits, to facilitate precise digital impressions in restorative dentistry.

The company’s products are classified as Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 Apollo Implant Components manufacture?

Apollo Implant Components specializes in dental implant abutment analogs intended for single-use intraoral scanning. These devices are designed to create precise digital impressions in restorative dentistry, helping dental professionals capture accurate scans of dental implants. The company’s products include variants like single-wing and double-wing adapters, as well as complete scanning kits.

Where is Apollo Implant Components based?

The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs medical device authorization in the country.

Which regulatory registries list Apollo Implant Components’ devices?

Apollo Implant Components’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators verify product details.

How are Apollo Implant Components’ devices classified under medical device regulations?

The company’s dental implant abutment analogs fall under Class I medical device classification. This classification is typically assigned to low-risk devices, such as single-use scanning adapters, where the risk to patients is minimal and regulatory oversight is streamlined.

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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LinkedIn
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Facebook
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Email
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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
439457408

Catalogue (9)

DeviceModel / ReferenceRegistriesClassStatus
DIRECTscan™ Adapter Single Wing-D DS1000-09D
FDA UDI
Class IActive
DIRECTscan™ Adapter Single Wing-A DS1000-09A
FDA UDI
Class IActive
DIRECTscan™ Adapter Single Wing-C DS1000-09C
FDA UDI
Class IActive
DIRECTscan™ Adapter Single Wing-B DS1000-09B
FDA UDI
Class IActive
DIRECTscan™ Adapter Double Wing-F DS2000-09F
FDA UDI
Class IActive
DIRECTscan™ Adapter Double Wing-H DS2000-09H
FDA UDI
Class IActive
DIRECTscan™ Adapter Double Wing-E DS2000-09E
FDA UDI
Class IActive
DIRECTscan™ Adapter Double Wing-G DS2000-09G
FDA UDI
Class IActive
DIRECTscan™ Adapter Kit - Complete DS-Kit
FDA UDI
Class IActive

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