Identifiers
- 510(k) Number
- K071551 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 QuickBridge Cylinder and Cap is a dental implant accessory designed for immediate load restoration in endosseous dental implant procedures. It consists of a non-hexed titanium alloy cylinder and a polyetheretherketone (PEEK) cap, serving as a provisional bridge component. The device threads onto Biomet 3i conical abutments with a 4.8 mm margin diameter, facilitating secure attachment for provisional restorations. Its construction supports quick and stable provisional bridge pickup during clinical procedures.
This device is supplied as a reusable accessory for use in dental clinical settings by practitioners. The titanium cylinder threads onto Biomet 3i conical abutments, while the PEEK cap snaps over the cylinder to enable provisional bridge attachment. It is intended for use with Biomet 3i implant systems and has received FDA 510(k) clearance under the Dental advisory committee category. The product is distributed by Biomet 3i, Inc., and is identified by the FDA K-number K071551.
Frequently asked questions
What is the QuickBridge Cylinder and Cap used for?
The QuickBridge Cylinder and Cap is designed specifically for immediate load restoration in endosseous dental implant procedures. It allows clinicians to attach provisional bridges quickly and securely to Biomet 3i conical abutments, ensuring stability during early-stage implant healing. This reduces chair time and enhances patient comfort by enabling faster provisional restoration placement.
How is the QuickBridge Cylinder and Cap supplied and intended for use?
This device is supplied as a reusable accessory for clinical use by dental practitioners. It consists of a titanium alloy cylinder that threads onto Biomet 3i conical abutments, paired with a PEEK cap that snaps over the cylinder to secure provisional bridge components. Its design ensures compatibility exclusively with Biomet 3i implant systems, streamlining workflow for immediate-load scenarios.
Is the QuickBridge Cylinder and Cap single-use or reusable?
The QuickBridge Cylinder and Cap is intended for reusable clinical use. Its durable titanium alloy construction and modular design allow for repeated sterilization and application across multiple procedures, provided proper cleaning and maintenance protocols are followed. This makes it cost-effective for practices performing frequent immediate-load implant restorations.
What are the key dimensions or specifications for attachment?
The titanium cylinder threads onto Biomet 3i conical abutments with a 4.8 mm margin diameter, ensuring a precise and secure fit. The PEEK cap snaps over the cylinder to facilitate provisional bridge pickup, creating a stable interface for provisional restorations. These specifications are optimized for compatibility with Biomet 3i’s implant system components.
How should the QuickBridge Cylinder and Cap be stored?
The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. Since it is reusable, it must be thoroughly cleaned and sterilized between uses following standard dental instrument protocols. Proper storage prevents corrosion of the titanium cylinder and degradation of the PEEK cap, ensuring long-term 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: QUICKBRIDGE TM CYLINDER AND CAP (K071551) — FDA 510 (k) | Innolitics, Quickbridge Tm Cylinder And Cap 510 (k) FDA Premarket Notification ..., PDF Biomet 3i, Inc. Special 510(k) Premarket Notification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071551 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet 3i, Inc.
Sources (1)
- FDA 510(k) K071551 24 fields · synced Oct 1, 2026