IBO - DIGITAL Analog + Fixation Screw for Printed model for Analog INTHEX NP (3.5mm) ( includes Analog ) - # HEI-35301
Description
DIGITAL Analog + HEI-35301
DESCRIPTION
IBO component, reference HEI-35301, DIGITAL Analog + HEI-35301. Part of the IBO Conical Reactive product family — used in IBO's implant + prosthetic system per the specified application.
CLINICAL APPLICATION
Used in IBO Conical Reactive system workflows per the component's designated application. Specific clinical use must be determined by the treating practitioner from the IBO catalogue and the IBO Instructions for Use for this reference.
PLATFORM & COMPATIBILITY
Pairs with the IBO Conical Reactive system per its catalogue designation. Confirm specific implant-platform compatibility via the IBO catalogue.
TECHNICAL SPECIFICATIONS
| Manufacturer reference | HEI-35301 |
|---|---|
| Brand | IBO |
| Brand model | ZIMMER |
| Designation | DIGITAL Analog + HEI-35301 |
| Material | Medical-grade titanium alloy |
| Package | 1pk |
| Regulatory | CE marking MDR · ISO 13485:2016 · AEMPS licence |
MATERIALS & SURFACE
Machined from medical-grade Ti-6Al-4V ELI titanium (Grade 5), ASTM F136 / ISO 5832-3, selected for biocompatibility, mechanical strength and chemical stability in the oral environment.
All materials and processes comply with current regulations and are subject to full traceability from raw material to final validation.
STERILIZATION & HANDLING
Supplied in the manufacturer's validated condition for clinical use. Follow the package insert and IBO Instructions for Use for handling, storage and any chairside preparation steps. Do not modify the geometry or surface in any way; doing so compromises both clinical fit and regulatory clearance.
Single-use device. Single patient, single procedure. Discard unused components per local biohazard regulations.
QUALITY ASSURANCE
IBO operates under ISO 13485:2016 quality management for the manufacturing of medical devices, holds the AEMPS Spanish Agency of Medicines and Medical Devices licence, and every IBO component carries the CE marking MDR, assessed by a Notified Body.