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: 95mm Z-Protocol Active
Traceability: Verified Lot-Specific
Compatibility Report // Zirkonzahn®

Precision 95mm Protocol for Zirkonzahn®.

The strict-tolerance alternative for M1, M4, and M5 milling units. ASTM F136 ELI compliant material engineered to eliminate the "95mm Trap."

Configuration Alert

95mm Diameter Only. This geometry is engineered specifically for Zirkonzahn orbit holders. NOT compatible with 98mm Open Systems (Roland/VHF/Imes-Icore).

Diameter 95mm (h7)
Fitment ZZ Orbit
Grade Ti-6Al-4V ELI
95mm Disc Micrometer Verification
Fig 1. Dimensional Calibration
Visual Audit Status: Verified

Forensic visualization of Z-type step geometry and surface finish prior to vacuum packaging.

Z-System Dimensional Data

Parameter ValidTi Value Impact on ZZ Holder
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
Outer Diameter 95.00mm (-0.02mm) Zero Jamming Risk during insertion/extraction
Thickness Range 10mm — 25mm Full Bridge Support (M1/M5 Compatibility)
Surface Texture Machined (Matte finish) Laser Micrometer Verified Reflectivity
Ovality (Roundness) < 0.005mm Protects spindle lifetime from vibration
Ovality Analysis
Fig 3. Diameter Verification Protocol (h7) | Measurement Source: Mitutoyo LSM-6900
Risk Addressed

Ovality & Holder Jamming

Zirkonzahn holders require perfect circularity. Generic 'cast' bars often have ovality issues, causing the 95mm disc to seize in the holder orbit or causing uneven tension on the spindle.

"ValidTi discs are centerless ground and turned to ensure Perfect Roundness (Ovality < 5 microns). This precision ensures a 1:1 sliding fit with Zirkonzahn® original orbit holders, eliminating mechanical stress during the milling of long-span bridges."

Verification & Compliance

FDA Registered Manufacturing Facility
MDR Class IIa Annex I
ZZ-STRAT Strategy Compatible

System Response Time: < 24h for Technical File Requests.

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