Dental implants · Digital dentistry

Straumann Implant Systems Engineered for Predictable Digital Workflows

Evaluate Straumann surgical kits, SLActive surface protocols, intraoral scanning, CAD/CAM milling, and prosthetic components against testable clinical, biocompatibility, and interoperability criteria.

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Dental implant surgical cassette and digital scan workstation

Why clinical teams shortlist Straumann

Six Checkpoints Before an Implant Platform Commit

Surface chemistry you can document

SLActive hydrophilic titanium claims must map to IFU indication, storage conditions, and biocompatibility ISO 10993 evidence packages.

Guided surgery that stays sterile

Surgical guide fit, drill stop geometry, and cassette sterilization cycles (steam / EO) belong in the same acceptance packet.

Torque protocol honesty

Insertion torque windows and abutment screw preload only help when torque wrench calibration intervals are written down.

Digital scan body fidelity

Intraoral scan body libraries, CAD/CAM abutment fit, and Ti-base tolerances need version-controlled STL / library releases.

UDI and lot traceability

UDI-DI / UDI-PI labeling, GUDID entries, and recall lookup paths stay reference-specific across implant and prosthetic SKUs.

QMS and risk files

ISO 13485 scope, ISO 14971 risk-benefit analysis, DHF/DMR access, and PMS plans remain part of every clinical evaluation.

Procurement workbench

Translate a Catalog Reference into Acceptance Criteria

Figures below are planning ranges for dental implant workflows, not guarantees for every Straumann reference. Confirm IFU, 510(k) / CE MDR labeling, and regional availability.

Platform fitMap diameter / length matrix, connection type, and bone quality indication against surgical protocol tables
Surface & biocompatibilitySLActive or equivalent hydrophilic claims; ISO 10993 cytotoxicity / sensitization / implantation evidence on file
Sterility assuranceSAL 10⁻⁶ packaging under ISO 11607; confirm shelf life and shipping validation for each lot
Regulatory pathConfirm FDA 510(k) cleared or CE marked under MDR 2017/745 status by exact catalog reference
Cassette layoutBLT / BLX / Standard Plus kit maps; drill stop sequence; torque wrench compatibility
ReprocessingSteam autoclave 121°C / 134°C cycles, EO where labeled, AAMI ST91 documentation on request
Guided surgerySleeve height, drill length, and guide retention must match the digital plan export version
BoundaryInstrument reuse count and wear inspection intervals govern usable kit life independent of implant SKU
Scan body libraryVersion-controlled libraries for RC / NC / SC platforms; digital analog fit checks
Intraoral scannerAccuracy envelope, open STL export, and chairside CAD/CAM handoff latency
InteroperabilityPractice management export, DICOM CBCT merge where indicated, and cybersecure update path
BoundaryScan quality depends on soft-tissue management, saliva control, and operator training—not scanner model alone
Ti-base & abutmentsEmergence profile library, screw channel angulation, and milling cutter compatibility
Material optionsTitanium, zirconia, and hybrid restorative stacks with IFU torque values
Lab workflowCARES scan body / abutment path, closed-tray impression fallback, and lot-level UDI on prosthetic components
BoundaryOcclusal load, cement gap, and lab milling accuracy can shift fit independent of implant platform

Care settings

Where Straumann Implant Workflows Are Evaluated

Shortlist by care setting first—then map implant platform, guided surgery, and digital lab handoff to that workflow.

Dental Practices & Groups

Single-tooth to full-arch case mix with chairside scanning and same-day provisional paths.

Oral Surgery Centers

High-volume placement days with cassette turnover, guided sleeves, and sterile corridor logistics.

Dental Laboratories

CAD/CAM milling, Ti-base libraries, and scan body version control across restorative stacks.

Hospital Dental Departments

Value analysis packets with FDA 510(k) / CE MDR evidence, UDI, and infection-control SOPs.

Specialty Periodontics

Soft-tissue management, membrane options, and staged regenerative workflows.

Academic Teaching Clinics

Protocol-driven training kits, torque documentation, and supervised guided surgery labs.

DSO Networks

Standardized SKU formularies, GPO pricing, and multi-site inventory with lot recall sync.

Remote Monitoring Pilots

Where connected healing / compliance tools are in scope, map FHIR observation boundaries separately from implant IFU.

Regulatory recognitions

Compliance Evidence Procurement Teams Expect

FDA 510(k)

FDA 510(k) Cleared

Clearance statements are reference-specific. Request the applicable K-number summary for each implant or instrument family.

CE MDR

CE Marked under MDR 2017/745

EU MDR technical documentation and Notified Body certificates available by market and device class.

ISO 13485

ISO 13485:2016

Quality management system covering design controls, CAPA, supplier qualification, and complaint handling.

ISO 10993

ISO 10993 Biocompatibility

Cytotoxicity, sensitization, irritation, and implantation endpoints maintained in the biological evaluation file.

70+ Markets with Straumann dental distribution coverage*
ISO 13485 QMS scope maintained for implant & prosthetic lines*
UDI Lot-level UDI-DI / UDI-PI labeling on implant SKUs*
Digital Scan body libraries versioned for CAD/CAM handoff*

*Planning indicators for professional evaluation. Confirm current certificates, labeling, and installed-base figures for your market.

Schedule a Clinical Pilot for Your Implant Workflow

Bring your care setting, procedure mix, and digital stack. We will map implant platform options, guided surgery kits, and documentation packets—not a one-size brochure.

  • Reference-specific FDA 510(k) / CE MDR status
  • Surgical cassette & sterilization validation docs
  • Scan body / Ti-base library version notes
  • UDI recall lookup and SDS on request

Request a pilot conversation