SYSTEM STATUS: FDA ACTIVE ISO 13485 Valid MDR Ready
Establishment SinoTitanium
Metals
FEI No. 3033849259
Status Valid
[ISO 13485:2016 VERIFIED] // VDS- PROTOCOL ACTIVE
RESTRICTED ACCESS: Materials classified for Medical Device Manufacturing (Class IIa/IIb) only. Not for consumer, automotive, or jewelry applications.
System Status: Active

Born from Grade 0A.

Purity is not inspected; it is inherited. ValidTi™ starts exclusively with Grade 0A Titanium Sponge—the same raw material standard used for aerospace rotors.

FDA Registration
Active (FY2025)
Material Standard
ASTM F136 ELI
Global Inventory
Dispatch Ready
ValidTi Titanium Disc

The Cost of Micro-Chaos

Verification: Inconsistent Grain Structure = Tool Wear & Fracture Risk.

Metric Generic Ti ValidTi™ Reference Clinical Impact
Grain Size (ASTM E112) G5 (Coarse) G10+ (Fine) +30% Tool Life Extension
Alpha Case Depth > 0.05mm Zero (Pickled) Eliminates Ceramic De-bonding
Iron (Fe) Content Variable (~0.25%) Controlled (< 0.13%) Ensures Biocompatibility Audit Pass
Microscopic comparison

Fig 1.0: Metallographic Comparison at 500x Magnification.

Pass: V-205

Material Specification Ledger

Base parameters for ValidTi Grade 23 ELI (Extra Low Interstitial).

Property
ValidTi Typical
Raw Material
< 0.12%
Raw Material
< 0.12%
Raw Material
< 0.12%
Tensile Strength
915 MPa
Yield Strength (0.2%)
840 MPa
Elongation
14%

Documentation Infrastructure / Technical Vault

Full Material Datasheet (Standard Color) File: ValidTi-TDS-ST-COL.pdf // REV 4.2

System Log / Traceability Feed

SYS.UTC: 2025-12-20-02:24
2025-05-12 [COMPLIANCE] FDA Establishment Registration updated for FY2026. Status: ACTIVE.
2025-04-20 [INVENTORY] New batch of 16mm h7 Rods (Lot #TI-2504A) cleared QA. Total trace active.
2025-03-15 [STRATEGY] Updated 'Anti-Galling' milling strategy file (v4.2) released for high-speed hubs.
2025-02-10 [SYSTEM] Log initialization sequence complete. All manufacturing nodes synchronized.

Audit-Ready Infrastructure

We do not sell 'Certificates'; we sell the certainty of passing your audit through transparent raw data.

FEI: 301245...
FDA Registered
Status: Active
NQA Standard
ISO 13485:2016
Status: Verified
MDR Protocol
CE Class IIa
Status: Transition

OEM & Private Label Infrastructure

We provide the metallurgical backbone, factory compliance, and regulatory hosting for global dental brands.

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