← Back to catalogue

DenQ Sub SLA Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240977

by Denq

Identifiers

510(k) Number
K240977 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 DenQ Sub SLA Implant System is a dental implant system designed for use in partially or fully edentulous mandibles and maxillae. It features a platform-switched design intended to support single or multiple-unit restorations, including cemented or screw-retained options. The SLA surface is engineered to facilitate bone-to-implant contact and assist in maintaining the crestal bone margin.

This system is supplied for clinical use as a dental implant solution. It has received FDA 510(k) clearance under the K240977 submission. Users should refer to the manufacturer's provided documentation for specific storage, handling, and surgical application protocols.

Frequently asked questions

What is the primary clinical indication for the DenQ Sub SLA Implant System?

This system is designed for use in patients with partially or fully edentulous mandibles and maxillae. It supports both single and multiple-unit restorations, which can be either cemented or screw-retained depending on the specific clinical requirements.

What is the purpose of the SLA surface on this implant?

The SLA surface is specifically engineered to facilitate bone-to-implant contact. By promoting this integration, the surface design assists in maintaining the crestal bone margin around the implant site.

Has the DenQ Sub SLA Implant System received regulatory clearance?

Yes, this device has received FDA 510(k) clearance under submission number K240977. This indicates that the system has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Where can I find specific surgical protocols for this system?

Users should refer to the manufacturer's provided documentation for all specific storage, handling, and surgical application protocols. These documents contain the necessary instructions to ensure the device is used according to the manufacturer's specifications.

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: PDF Andrew I. Steen -S, DenQ Sub SLA Implant System (K240977) - Medical Device Navigator, DenQ, DenQ Sub SLA Implant System (K240977) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Denq

Sources (1)

  • FDA 510(k) K240977 24 fields · synced Sep 23, 2026