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Intra-Lock International

US

Last updated May 23, 2026

What Intra-Lock International makes

Intra-Lock International manufactures dental implant systems, including reusable fixtures like drill bits and attachments for dental drilling systems, as well as preformed, single-use temporary suprastructures for implants. Their portfolio also includes reusable general-purpose bowls and line-powered dental power tool handpieces. Additionally, they produce composite dental bone matrix implants and systems for concentrating haematological samples.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Intra-Lock International operates from 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 Intra-Lock International manufacture?

Intra-Lock International specializes in dental and haematological devices. Their portfolio includes dental implant systems, reusable fixtures like drill bits and attachments for dental drilling systems, single-use temporary implant suprastructures, reusable general-purpose bowls, and line-powered dental power tool handpieces. They also produce composite dental bone matrix implants and systems for concentrating haematological samples.

Where is Intra-Lock International based?

Intra-Lock International is headquartered in the United States. The company’s location is relevant for regulatory inquiries, as it determines the jurisdiction under which its devices may be authorized.

Which regulatory registries list Intra-Lock International’s devices?

Intra-Lock International’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the US, ensuring traceability and compliance with regulatory requirements.

How are Intra-Lock International’s devices classified under FDA regulations?

Intra-Lock International’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorization.

Are Intra-Lock International’s devices used in both dental and non-dental applications?

Yes, Intra-Lock International’s devices span both dental and haematological applications. Their dental-focused products include implants, drilling tools, and bone matrix materials, while their haematological concentrate system is designed for medical laboratory use. This dual focus reflects their expertise in precision instruments for healthcare settings.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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Catalogue (1262)

Page 26 of 26
DeviceModel / ReferenceRegistriesClassStatus
Intra-Lock International Angled Prosthetic Abutments K040205
FDA 510(k)
Class IIActive
Endossous Implants K021322
FDA 510(k)
Class IIActive
Intra-Lock Dental Implants K133613
FDA 510(k)
Class IIActive
Intra-Lock Dental Implants With Blossom K103194
FDA 510(k)
Class IIActive
Intra-Lock Dental Implants With Blossom 3.4mm Implant Angled Abutments K111199
FDA 510(k)
Class IIActive
Intra-Lock Hydroxyapatite Coated Implants K031322
FDA 510(k)
Class IIActive
Transitional Implants K021915
FDA 510(k)
Class IIActive
Mini Drive-Lock Dental Implant System Prosthetics K080598
FDA 510(k)
Class IIActive
Mini Drive-Lock Dental Implant System K070601
FDA 510(k)
Class IIActive
Reoss Powder, Reoss Putty, Reoss Gel, Models R-1, Rp-1, Rg-1 K082419
FDA 510(k)
Class IIActive
Intra-Lock Op Dental Implant K130140
FDA 510(k)
Class IIActive
Milo Dental Implant System K050970
FDA 510(k)
Class IIActive

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