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

OEM & Manufacturing Services

From white-label branding to bulk wholesale supply and custom CNC manufacturing. ISO 13485 certified facility with FDA registration and full regulatory hosting.

PREMIUM

Private Label OEM

Launch your own branded dental titanium line. We handle manufacturing, quality control, regulatory documentation, and technical file hosting.

  • ✓ Custom packaging & labeling
  • ✓ FDA registration under your brand
  • ✓ Technical file hosting (EU MDR/CE)
  • ✓ Regulatory audit support
  • ✓ Marketing asset library
MOQ: 50 units per SKU
Lead Time: 4-6 weeks
EXPLORE PRIVATE LABEL →
VOLUME

Wholesale Factory-Direct

Direct from our ISO 13485 certified facility in Xi'an, China. No middlemen. Transparent pricing. Full traceability.

  • ✓ 30-50% cost savings vs. branded
  • ✓ Bulk pricing (100+ units)
  • ✓ Regional distributor programs
  • ✓ Flexible payment terms
  • ✓ Consignment options available
MOQ: 100 units (mixed SKU)
Lead Time: 2-3 weeks
GET WHOLESALE PRICING →
CUSTOM

Custom CNC Turning

Precision CNC turning for custom implant components, abutments, and medical device parts. Swiss-type and multi-axis capabilities.

  • ✓ Citizen & Star Swiss lathes
  • ✓ Tolerances to ±0.005mm
  • ✓ Ra 0.8 surface finish
  • ✓ Prototype to production runs
  • ✓ NDA protection standard
MOQ: 25 units (prototyping)
Lead Time: Quote + 3-4 weeks
REQUEST CUSTOM QUOTE →

The "0A" Difference: Why Origin Matters

THE INDUSTRY STANDARD (GRADE 0/1)

Most dental discs start from standard Grade 0 or Grade 1 sponge, or worse—reverted scrap (recycled titanium). This introduces invisible "inclusions" and inconsistent oxygen levels.

Result: Spindle "Hard Spots" & Tool Micro-Fractures.
VALIDTI EXCLUSIVE

THE VALIDTI STANDARD (GRADE 0A)

We utilize Grade 0A Sponge—the highest purity tier in the metallurgical chart. 100% Virgin material with aerospace-level certification.

  • • Fe (Iron) < 0.12%: Higher bio-compatibility.
  • • Micro-Purity: Zero high-density inclusions.
Result: Zero Hard Spots. 30%+ Tool Life Extension.

CERTIFIED FACILITY

ISO 13485
Medical Device QMS
FDA REG
Establishment #3033849259
MDR READY
EU Regulatory Compliance
10+ YRS
Medical Manufacturing

Service FAQ

Why is ValidTi more expensive than generic discs?

It's in the genes. Generic discs often blend recycled scrap to lower costs. ValidTi uses 100% Virgin Grade 0A Sponge. We pay a premium for raw material purity so you don't pay a premium for broken tools and remakes.

Can you host our Technical Files for EU MDR?

Yes. For our Private Label partners, we provide full regulatory hosting services, including access to our biocompatibility data, clinical evaluation reports, and factory quality logs required for CE marking and MDR compliance.

Ready to Start Your Project?

Contact our OEM team for a confidential consultation and pricing proposal.

INITIATE INQUIRY → TECHNICAL CONSULTATION