← Back to catalogue

SQ IS System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090825

by Neobiotech. co., ltd

Identifiers

510(k) Number
K090825 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 SQ IS System is a dental implant system classified under the product code DZE, designed for the surgical placement of endosteal dental implants in the alveolar or basal bone of the mandible or maxilla. It provides structural support and retention for dental prostheses, such as bridges, single-tooth replacements, or overdentures. The system includes sterile implant bodies, abutments, and associated surgical instruments required for implantation.

This system is intended for use in dental surgical settings and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of July 16, 2009. The device is supplied sterile and is intended for single-use per the manufacturer’s specifications. No additional regulatory markings or MRI safety classifications are noted in the available data. The system is distributed by Neobiotech Co., Ltd., with the applicant listed as Eugene Bang.

Frequently asked questions

What is the SQ IS System used for?

The SQ IS System is designed for the surgical placement of endosteal dental implants in the alveolar or basal bone of the mandible (lower jaw) or maxilla (upper jaw). It provides structural support and retention for dental prostheses, such as bridges, single-tooth replacements, or overdentures, ensuring stable restoration of lost teeth.

How is the SQ IS System supplied?

The SQ IS System is supplied sterile, ready for immediate use in dental surgical settings. It includes implant bodies, abutments, and associated surgical instruments required for implantation. The manufacturer specifies it for single-use only, meaning each system is intended for one surgical procedure.

Is the SQ IS System reusable?

No, the SQ IS System is intended for single-use only, as specified by the manufacturer. Reusing components could compromise sterility, patient safety, and the integrity of the implant system, potentially leading to complications such as infection or implant failure.

What regulatory approval does the SQ IS System hold?

The SQ IS System has received FDA 510(k) clearance under the Traditional pathway, with a decision date of July 16, 2009. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness.

Does the SQ IS System include any special storage instructions?

While specific storage instructions are not detailed in the provided data, sterile medical devices like the SQ IS System should generally be stored in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Follow the manufacturer’s guidelines or accompanying documentation for precise storage recommendations to maintain sterility and functionality.

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: Sq Is System - Beudamed, Device Listing 1033737958 - FDA.report, DEVICE: Neobiotech Implant System (08809486296820)

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
Neobiotech. co., ltd
FDA Applicant
Neobiotech Co., Ltd.

Sources (1)

  • FDA 510(k) K090825 24 fields · synced Oct 1, 2026