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CAMLOG/CONELOG Progressive-Line Implants

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193401

by ALTATEC GmbH

Identifiers

510(k) Number
K193401 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)

The CAMLOG/CONELOG Progressive-Line Implants are dental implants designed for the replacement of missing teeth. These implants are part of the progressive-line series, featuring a conical connection system for enhanced stability and integration with abutments, facilitating osseointegration in the alveolar bone.

These implants are supplied sterile and intended for single-use in dental procedures. They are regulated under FDA 510K clearance and MDR compliance, with a product code classification of DZE. Available in various sizes and configurations, they are intended for use in oral and maxillofacial surgery settings, adhering to standard aseptic techniques for implantation.

Frequently asked questions

What types of dental procedures are these implants primarily used for and why is the conical connection system important?

The CAMLOG/CONELOG Progressive-Line Implants are designed specifically for replacing missing teeth in oral and maxillofacial surgery. The conical connection system enhances stability and integration with abutments, which helps improve osseointegration—the process where bone grows directly into the implant surface. This design reduces micromotion at the implant-abutment interface, promoting stronger and more predictable long-term outcomes.

Are these implants reusable or single-use, and how should they be handled to maintain sterility?

These implants are intended for single-use only and are supplied sterile to ensure patient safety. Since they are not designed for reuse, they must be handled using strict aseptic techniques during dental procedures. Once opened or exposed, they should not be reused, and any unused portion must be discarded according to sterile medical device protocols.

What size and configuration options are available for these implants, and how might that affect their use?

The CAMLOG/CONELOG Progressive-Line Implants come in various sizes and configurations to accommodate different patient anatomies and clinical needs. The availability of multiple diameters and lengths allows for customized placement in the alveolar bone, ensuring better fit and stability. This versatility helps clinicians select the most appropriate implant for each patient’s specific dental structure and treatment plan.

How should these implants be stored before use, and what precautions should be taken?

Since these implants are sterile, they should be stored in their original packaging until ready for use, following the manufacturer’s instructions. The packaging must remain intact and unopened to preserve sterility. Storage should occur in a clean, dry environment away from direct sunlight or extreme temperatures, as this helps maintain the integrity of the implant surface and packaging materials.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
ALTATEC GmbH

Sources (2)

  • FDA 510(k) K193401 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026