Development and manufacturing partner for miniature implants and medical technology instruments
A.K. TEK GmbH
Hagen (58093), GermanyNew on Amplifa
Development and manufacturing partner for medical technology
A.K. TEK GmbH is a family-owned company in Hagen and has been a development and manufacturing partner in medical technology for over three decades, especially for dental implantology and microsurgery. The company manufactures miniature products such as dental implant systems, small implants for reconstructive surgery, finger joints, housings for artificial intervertebral discs, bone screws, and miniature instruments for physicians. The value chain covers the complete manufacturing process, from the initial idea through design in CAD systems (Siemens NX, AutoCAD, Inventor) with finite element analysis to production by precision turning, milling and turn-milling, EDM, plastic injection molding, and laser welding. A broad range of surface technologies (blasting, etching, anodizing, electropolishing, passivation, sintering, body coating) and a cleanroom certified to ISO Class 7 / EU-GMP Grade C for part cleaning, assembly, and packaging complete the portfolio. Production ranges from single parts to series; products are manufactured individually for customers in close collaboration with implantologists, clinics, and institutes.
- Site
- Hagen
- Processes
- Turning/milling (precision turning, milling, turn-milling of miniature products), EDM, Plastic injection molding, Laser welding, Laser marking and engraving, Blasting, Etching, Anodizing
- Materials
- Titanium, Plastics, Aluminum, CAD/CAM design (Siemens NX, AutoCAD, Inventor), Finite element analysis, Fatigue testing
- Certificates
- DIN EN ISO 13485 / Annex II Directive 93/42 EEC, Cleanroom qualification DIN EN ISO 14644-1/4, EU-GMP Grade C, ISO 7, Category 3, Cleanroom ISO 7 / EU-GMP Grade C / Category 3 (DIN EN 14644-1/4, DIN EN 17141)
- Industries
- Medical technology, Dental implantology, Spine surgery, Hand surgery, Microsurgery
- 01
Product development and design (CAD/CAM, FEM)
- 02
Precision turning, milling, turn-milling, EDM, plastic injection molding,
- 03
Surface technology (blasting, etching, anodizing, electropolishing, passivation,
- 04
Cleanroom: part cleaning, component assembly, packaging
- 05
Sterilization of medical technology products
- 06
Testing, verification, validation, documentation
Materials and processes
Titanium
Material for miniature products made by precision turning, milling, and turn-milling in medical technology.
Plastics
Material for plastic injection molding of components.
Aluminum
Material for anodizing as a surface treatment process.
CAD/CAM design (Siemens NX, AutoCAD, Inventor)
Design of production-ready solutions including finite element analysis.
Finite element analysis
Study-supported product optimization and functional substantiation of implant systems.
Fatigue testing
Test method for substantiating and optimizing implant solutions.
Hagen site
Hagen
DEDevelopment, manufacturing, cleanroom
- Lot size
- Single part to series
- Materials
- Titanium, medical technology materials, plastics, aluminum
- Cleanroom (ISO Class 7, EU-GMP Grade C, Category 3 per DIN EN 17141)
- 3D measuring machine (more than three methods)
- Optical measuring machines
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Turning/milling (precision turning, milling, turn-milling of miniature products)Machining | – | – | – | Single part – Series | Titanium, Medical technology materials |
| EDMMachining | – | – | – | – | – |
| Plastic injection moldingPlastics | – | – | – | – | Plastics |
| Laser weldingJoining | – | – | – | – | – |
| Laser marking and engravingSurface | – | – | – | – | – |
| BlastingSurface | – | – | – | – | – |
| EtchingSurface | – | – | – | – | – |
| AnodizingSurface | – | – | – | – | Aluminum |
| ElectropolishingSurface | – | – | – | – | – |
| PassivationSurface | – | – | – | – | – |
| Laser treatment (surface processing)Surface | – | – | – | – | – |
| SinteringSurface | – | – | – | – | – |
| Body coatingSurface | – | – | – | – | – |
| Part cleaning (cleanroom technology, ISO 7 / EU-GMP Grade C / Category 3 per DIN EN 17141)Surface | – | – | – | – | – |
| Component assembly (cleanroom)Assembly | – | – | – | – | – |
| PackagingAssembly | – | – | – | – | – |
| Sterilization of medical technology productsSurface | – | – | – | – | – |
| 3D measurement (more than three methods)Testing | – | – | – | – | – |
| Optical measuring machinesTesting | – | – | – | – | – |
| Roughness measurementTesting | – | – | – | – | – |
| Tensile/compression testingTesting | – | – | – | – | – |
| Development with CAD systems (Siemens NX, CAD/CAM, FEM, AutoCAD, Inventor)Engineering | – | – | – | – | – |
| Finite element analysis (FEM) and fatigue testingTesting | – | – | – | – | – |
| Manufacture of medical technology miniature products (dental implants, implant systems,Machining | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| 3D measuring machine | – | – | – | – | Hagen |
| Optical measuring machine | – | – | – | – | Hagen |
| Cleanroom (ISO Class 7, EU-GMP Grade C, Category 3 per DIN EN 17141) | – | – | – | – | Hagen |
Additional services
Certificates and quality assurance
Quality assurance is carried out in accordance with QM EN ISO 13485 (Annex II Directive 93/42 EEC) with continuous process measurement. Available testing and measurement methods include 3D measuring machines (more than three methods), optical measuring machines, roughness measurement, and tensile/compression testing.
| Evidence | Hagen |
|---|---|
| DIN EN ISO 13485 / Annex II Directive 93/42 EEC | |
| Cleanroom ISO 7 / EU-GMP Grade C / Category 3 (DIN EN 14644-1/4, DIN EN 17141) |
History
Over three decades of activity as a development and manufacturing partner in medical technology, especially for dental implantology, in close collaboration with implantologists, clinics, and institutes.