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Camlog and ConeLog Abutments for Screw-Retained Restorations (ASR)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152509

by ALTATEC GmbH

Identifiers

510(k) Number
K152509 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Camlog and ConeLog Abutments for Screw-Retained Restorations (ASR) are dental implants designed for screw-retained prosthetic restorations. These abutments feature a high-precision, deep conical connection with indexing grooves and cams, ensuring stability and compatibility with both epicrestal and subcrestal implant positioning. They are categorized under dental implant components, specifically for use in restorative dentistry.

These abutments are supplied as part of the ConeLog Implant System and are intended for single-use applications in dental procedures. They are manufactured by Altatec GmbH and comply with FDA 510(k) clearance under the Traditional review pathway, classified under product code NHA. Sterility and regulatory compliance are ensured through the manufacturer’s quality control processes, adhering to MDR and FDA standards.

Frequently asked questions

Are these abutments designed for use with both epicrestal and subcrestal implant placements, and how does the conical connection contribute to stability?

Yes, the Camlog and ConeLog Abutments are specifically engineered for compatibility with both epicrestal and subcrestal implant positions. The high-precision, deep conical connection—paired with indexing grooves and cams—enhances stability by creating a secure, tight fit between the abutment and implant, reducing micromovement and improving long-term retention for screw-retained restorations.

Are these abutments intended for single-use or can they be reused in a clinical setting?

These abutments are explicitly supplied for single-use applications in dental procedures. The manufacturer’s design and quality control processes align with this use-case, ensuring sterility and compliance with regulatory standards like the MDR and FDA 510(k) clearance. Reuse is not recommended or supported by the manufacturer.

What regulatory pathways have these abutments undergone, and how does the manufacturer ensure compliance with sterility and quality standards?

The Camlog and ConeLog Abutments have received FDA 510(k) clearance under the Traditional review pathway (K152509) and comply with MDR (Medical Device Regulation) standards. Sterility and quality control are maintained through Altatec GmbH’s documented processes, which align with both regulatory frameworks to ensure safety and performance for single-use dental implant components.

How are these abutments supplied, and are they part of a larger system?

These abutments are supplied as part of the ConeLog Implant System by Altatec GmbH. They are not standalone items but are designed to integrate seamlessly within this system for screw-retained restorative dentistry, ensuring compatibility with the conical connection technology and other system components.

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: CONELOG Implant System by Camlog: the conical connection, CONELOG Implant System by Camlog: Dental Prosthetics, CAMLOG And CONELOG Abutments For Screw-retained Restorations (ASR)

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) K152509 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026