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Intra-Lock OP Dental Implant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130140

by Intra-Lock International

Identifiers

510(k) Number
K130140 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

An intra-lock OP dental implant is a dental implant designed to restore partially or fully edentulous patients. It is intended for use in either the mandible or maxilla to support removable or fixed prostheses, ranging from single tooth replacement to full arch reconstruction.

The device is supplied in sizes including 3.75mm, 4.0mm, and 4.75mm. It received FDA 510(k) clearance under K130140 with product code DZE and was determined to be substantially equivalent to a predicate device. The implant is manufactured by Intra-Lock International in Boca Raton, Florida, United States.

Frequently asked questions

What is the INTRA-LOCK OP DENTAL IMPLANT used for?

The INTRA-LOCK OP DENTAL IMPLANT is designed to restore partially or fully edentulous patients by supporting removable or fixed prostheses in the mandible or maxilla, ranging from single tooth replacement to full arch reconstruction.

What sizes is the INTRA-LOCK OP DENTAL IMPLANT available in?

The device is supplied in sizes including 3.75mm, 4.0mm, and 4.75mm, allowing clinicians to select appropriate dimensions based on patient anatomy and prosthetic needs.

How is the INTRA-LOCK OP DENTAL IMPLANT supplied and is it sterile?

The implant is supplied as a sterile, single-use device intended for direct implantation; sterility is maintained through validated manufacturing processes to ensure patient safety at time of use.

What regulatory pathway was used for the INTRA-LOCK OP DENTAL IMPLANT?

The device received FDA 510(k) clearance under K130140 with product code DZE, demonstrating substantial equivalence to a predicate device through a traditional review process.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home Page - INTRA-LOCK, Intra-Lock® Implants - Intra-Lock International, Inc. - PDF Catalogs ..., Intra-Lock System International Dental Implants | SpotImplant, index - Intra-Lock International, Inc. - PDF Catalogs | Technical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intra-Lock International

Sources (1)

  • FDA 510(k) K130140 24 fields · synced Oct 1, 2026