Identifiers
- 510(k) Number
- K090527 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 Sinus Quick It System is a dental device used in sinus lift procedures. It is designed for internal morse taper and internal octagon abutment connections with a tapered implant body shape.
The system is supplied as part of the SinusQuick sinus-lift instruments by Neobiotech Co., Ltd. It received FDA 510(k) clearance under K090527 on July 14, 2009, and is classified under product code DZE with review by the Dental advisory committee.
Frequently asked questions
What is the Sinus Quick It System used for?
The Sinus Quick It System is used in sinus lift procedures, which are dental surgeries to increase bone height in the upper jaw by lifting the sinus membrane and placing bone graft material.
How is the Sinus Quick It System supplied?
The system is supplied as part of the SinusQuick sinus-lift instruments by Neobiotech Co., Ltd., meaning it is provided as a component of a larger instrument set designed for sinus lift surgeries.
What type of connections does the Sinus Quick It System support?
It is designed for internal Morse taper and internal octagon abutment connections, which are specific types of implant-to-abutment interfaces that ensure secure and stable attachment in dental implantology.
What is the implant body shape of the Sinus Quick It System?
The system features a tapered implant body shape, which refers to the conical design of the implant that aids in primary stability and bone engagement during placement in the maxillary sinus area.
When did the Sinus Quick It System receive FDA clearance?
The Sinus Quick It System received FDA 510(k) clearance under K090527 on July 14, 2009, indicating it was found substantially equivalent to a legally marketed predicate device.
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: Neobiotech - Dental Implants Guide, PDF K090527 SINUS QUICK IT SYSTEM - 510kdatabase.net, SINUS QUICK IT SYSTEM 510 (k) K090527 - FDA.report, dental implant - Neobiotech Co., Ltd. - SinusQuick IT Internal (4.8 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090527 | Class II | Active |
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Manufacturer
- Manufacturer
- Neobiotech. co., ltd
- FDA Applicant
- Neobiotech Co., Ltd.
Sources (1)
- FDA 510(k) K090527 24 fields · synced Sep 28, 2026