SYSTEM STATUS: FDA ACTIVE ISO 13485 Valid MDR Ready
Establishment SinoTitanium
Metals
FEI No. 3033849259
Status Valid
[ISO 13485:2016 VERIFIED] // VDS- PROTOCOL ACTIVE
System Protocol: Multi-Unit Stability Verified

Multi-Unit Stability Protocol.

Pre-Milled Titanium Blanks (Grade 23 ELI) for fabricating implant-supported bars. Engineered for All-on-4/All-on-6 prosthetic frameworks with maximum flexural rigidity.

Material Ti-6Al-4V ELI
Standard ASTM F136
Tensile Str. 950 MPa
Tolerance h7 (±0.015mm)
Regulatory Clarity: ValidTi supplies raw material blanks for prosthetic fabrication. These are NOT finished medical devices. Final device validation (510(k)/CE/MDR) is the responsibility of the fabricating laboratory or manufacturer.

01 Clinical Applications

All-on-4/All-on-6 Bars

Multi-unit implant-supported frameworks connecting 4-6 dental implants. Provides rigid support for fixed full-arch prosthetics.

Overdenture Bars

Milled bars for implant-retained overdentures. Compatible with Locator attachments and clip retention systems.

Custom Suprastructures

Screw-retained frameworks with integrated abutment connections. CAD/CAM milled for precise passive fit.

02 Technical Specifications (ASTM F136)

Property ASTM F136 Requirement ValidTi Typical
Oxygen (O) Content < 0.10% ~ 0.13% High Toughness; Prevents Fatigue Failure
Iron (Fe) Content < 0.12% ~ 0.25% Superior Biocompatibility & Uniformity
Raw Material Source Grade 0A Virgin Sponge Standard Sponge (Scrap mix) Aerospace Grade Input; Zero Inclusions
Tensile Strength (Rm) ≥ 860 MPa 950-1050 MPa
Yield Strength (Rp0.2) ≥ 795 MPa 880-920 MPa
Elongation (%) ≥ 10% 12-15%
Reduction of Area (%) ≥ 25% 30-35%
Oxygen Content ≤ 0.13% 0.10-0.12%
Iron Content ≤ 0.25% 0.15-0.20%
Dimensional Tolerance Per Drawing h7 (0/-0.015mm)

* ELI = Extra Low Interstitial. Reduced oxygen and iron content for enhanced biocompatibility and ductility.

03 Available Formats & Dimensions

Cylindrical Rod Blanks

Precision-ground titanium rods for milling multi-unit bars on 5-axis CNC machines. h7 tolerance ensures consistent tool life.

Diameter Applications
Ø 10mm Single-unit bars, short-span
Ø 12mm Medium-span bars (4-unit)
Ø 14mm Full-arch bars (6-unit)
Ø 16mm Overdenture bars, heavy load
Length 55mm, 75mm, 100mm (custom avail.)

Rectangular Block Blanks

Solid titanium blocks for milling anatomically curved bars. Ideal for full-arch prosthetics requiring vertical dimension.

Dimensions Applications
15 × 20 × 50mm Partial-arch bars
18 × 25 × 70mm Full-arch bars (standard)
20 × 30 × 90mm Hybrid prosthetics (bar + gingiva)
Tolerance ±0.1mm (all dimensions)

04 Why Grade 23 ELI for Implant Bars?

Superior Mechanical Properties

  • High Strength-to-Weight Ratio
    950 MPa tensile strength at only 4.43 g/cm³ density. Allows thinner cross-sections without compromising rigidity.
  • Fatigue Resistance
    Excellent performance under cyclic masticatory loads (1,000,000+ cycles). Critical for long-term bar stability.
  • Passive Fit Compatibility
    Low modulus (110 GPa) allows micro-flexion to accommodate implant angulation without stress concentration.

Clinical & Regulatory Benefits

  • Proven Biocompatibility
    ISO 10993 compliant. Extra-low interstitials reduce risk of allergic reactions and inflammatory response.
  • FDA/CE Cleared Material
    ASTM F136 is listed in FDA Product Code EKO (Dental Prosthetic Materials). Streamlines device approval process.
  • Osseointegration Safe
    Tissue-contact safe. No cytotoxicity, genotoxicity, or mutagenicity in ISO 10993-5/10/11 testing.

05 Milling Guidelines for Implant Bars

Tool Selection

  • • Carbide End Mills (HRC 55+)
  • • 2-3 Flutes for Roughing
  • • 4-6 Flutes for Finishing
  • • TiAlN Coating Recommended

Cutting Parameters

  • • Speed: 2500-4000 RPM
  • • Feed: 300-800 mm/min
  • • DOC: 0.3-0.8mm (roughing)
  • • DOC: 0.05-0.15mm (finishing)

Coolant Strategy

  • • Wet Milling REQUIRED
  • • 5-8% Emulsion Coolant
  • • Through-Tool Coolant Ideal
  • • Prevent Galling & Work Hardening
Milling Optimization Tip

Grade 23 is prone to work hardening. Use sharp tools and maintain consistent feed rates. Interrupted cuts can cause tool deflection and poor surface finish. For detailed milling strategies, see our Bur Life Extension Protocol.

06 Quality Documentation (Included with Every Order)

Material Test Reports

  • EN 10204-3.1 MTC – Material Test Certificate with chemical composition and mechanical properties
  • Certificate of Analysis (CoA) – Lot-specific test results from accredited lab
  • Dimensional Inspection Report – Tolerance verification data

Regulatory Certificates

  • ISO 13485:2016 – Medical Device Quality Management System (Notified Body: NQA)
  • FDA Registration – Establishment No. 3033849259 (Active)
  • Biocompatibility Declaration – ISO 10993 compliance statement

07 Ordering Information

MOQ (Starter)
5 Units

Minimum order for initial testing. Includes full documentation package.

Lead Time
7-14 Days

Stock sizes ship within 7 days. Custom dimensions require 14 days.

Packaging
Individual

Each blank sealed in anti-corrosion packaging with lot traceability label.

Custom Specifications Available

Need specific dimensions, surface finishes, or pre-machined features? Contact our engineering team for custom blank production. Available for orders 50+ units.

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