Precision-engineered prosthetic interfaces for implant-supported dental restorations. Milled from certified medical-grade titanium alloy with strict dimensional control to ensure a secure, micro-gap-free connection at the implant platform level.
Technical Specifications
|
Parameter |
Specification |
|
Material Composition |
Titanium Grade 5 ELI (Ti-6Al-4V ELI), conforming to ASTM F136 and ISO 5832-3 |
|
Platform Compatibility |
Compatible with major implant systems (Nobel Biocare, Straumann, Zimmer Biomet, Osstem, Dentsply SImplant, etc.) |
|
Connection Type |
Internal hex, external hex, conical connection, and tri-channel options |
|
Collar Heights |
Available in 0.5 mm, 1.0 mm, 2.0 mm, and 3.0 mm configurations |
|
Surface Finish |
Grit-blasted bonding cylinder (Ra 1.2-1.8 um) for high retention with resin cements and adhesive caps |
|
Dimensional Tolerance |
plus-minus 0.005 mm on critical interface connections |
|
Delivery State |
Non-sterile; suitable for autoclave sterilization prior to clinical application |
Material & Manufacturing Process
Raw Material Verification
All components are machined from certified Grade 5 Ti-6Al-4V ELI (Extra Low Interstitial) bar stock. Incoming materials undergo positive material identification (PMI) and metallurgical testing to guarantee biocompatibility, high tensile strength, and resistance to cyclic fatigue.
High-Precision Machining
Produced on multi-axis Swiss-type CNC turning centers with live tooling. Critical interface dimensions-including anti-rotation indexes, screw access channels, and implant platform mating surfaces-are controlled within plus-minus 0.005 mm, ensuring uniform stress distribution and preventing screw loosening under masticatory loads.
Surface Texturing
The upper bonding zone undergoes controlled micro-blasting to optimize surface energy and mechanical interlocking. The emergence profile is precision-polished to support stable soft-tissue attachment and minimize plaque accumulation.
Clinical Indications & Restorative Scope
Designed for precision prosthetic reconstructions within digital dental workflows:
Restoration Types: Suitable for single-unit and multi-unit screw-retained or cement-retained restorations (including crowns and bridges).
Anatomical Placement: Applicable for both anterior and posterior regions, subject to the chosen platform diameter and crown emergence profile requirements.
Angle Correction Support: Compatible with angled screw channel (ASC) solutions where applicable, allowing screw access channel correction up to specific degrees for aesthetic optimization.
Quality Control & Regulatory Compliance
Operations adhere to ISO 13485:2016 quality management standards. Production lots are subject to strict verification protocols:
100% Dimensional Inspection: Automated optical and coordinate measuring machines (CMM) inspect connection geometry and screw seat tolerances for every lot.
Fatigue Resistance: Representative samples undergo dynamic fatigue testing per ISO 14801 to simulate long-term masticatory performance.
Cleanliness Standard: Post-machining ultrasonic cleaning in purified water lines eliminates organic residues, machining oils, and particulate debris.
Sterilization & Handling Guidelines
To ensure patient safety and compliance with clinical infection control standards:
Initial State: Components are delivered non-sterile. Ultrasonic cleaning and thorough inspection are recommended before laboratory processing or clinical trial fitting.
Autoclave Sterilization: Prior to clinical placement or intraoral try-in, components must undergo steam sterilization according to standard medical protocols (e.g., steam sterilization at 134 degrees Celsius for 3 to 18 minutes, depending on local institutional guidelines).
Single-Use Policy: Prosthetic screws are precision-engineered for single-patient use to maintain optimal preload retention and prevent fatigue failure. Titanium bases are intended for permanent prosthetic integration.
Traceability & Packaging Specifications
Laser Marking: Each titanium base is laser-marked with a unique lot number and platform identifier for complete traceability.
Cleanroom Packaging: Packed individually in clean, anti-static blister packs to prevent transit damage and surface contamination.
Regulatory Labeling: Labels include material specification, lot code, REF number, and compliance symbols ready for clinical or lab inventory management.
FAQ
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