Patient-individual titanium hybrid abutments for dental implant prosthetics – Custom-made Device under the MDR

EAP® Produktions- und Patentverwertungs-GmbH

Lorettostraße 26, 6060 Hall in Tirol · AustriaNew on Amplifa

2009Start of scientific research

45+Countries with patent protection

1Location (Hall in Tirol, AT)

1 pieceLot size (one-off production per patient)

GmbHLegal form

About EAP® Abutments

EAP® Produktions- und Patentverwertungs-GmbH, based in Hall in Tirol (Austria), manufactures patient-individual hybrid abutments for dental implant prosthetics. The EAP® Abutment (Extended Anatomic Platform) consists of a thin, patient-specific titanium shell: In the gingival area, only titanium is in contact, while the aesthetic restorative material (ceramics, polymers or 3D-printed crown materials) is located inside or behind the shell. Production is based on digital planning using STL data as a one-off production per patient; the titanium shell is milled, gold-anodized and bonded to the restorative material via a spring margin. The products are manufactured as Custom-made Devices under MDR Art. 2(3) exclusively on written prescription for a named patient and delivered to dentists and dental laboratories. According to the company, the concept is patented in over 45 countries; starting from the beginning of scientific research in 2009, the company also offers training for dentists and dental technicians through the EAP Skills Academy.

Site: Hall in Tirol
Processes: Manufacture of patient-individual hybrid abutments (EAP® Abutment, thin titanium shell, Digital planning and STL-based manufacturing, Anodization of the titanium abutment (gold-colored anodized, non-toxic re-anodization possible), Milling of the titanium shell (titanium housing can be milled away if required – local reworking), Polishing of the exposed titanium surface (local adjustment after recession, processing time, Assembly/bonding: adhesive joint between titanium shell and aesthetic restorative material, Manufacture of abutments upon written prescription (Custom-made Device under MDR Art. 2(3)), Manufacture of patient-individual titanium abutments (Custom-made Device under MDR Art. 2(3))
Materials: Titanium, Ceramics, Polymers (aesthetic restorative material), 3D-printed crown materials, Gold anodization, Polymers
Certificates: MDR Custom-made Device (Art. 2(3))
Founded: 2009
Industries: Dental medicine / implantology, Dental laboratories, Medical devices (Regulation (EU) 2017/745 – MDR), Medical devices (Regulation (EU) 2017/745)

01
Digital planning and STL-based manufacturing
02
Milling of the patient-specific titanium shell from titanium
03
Gold anodization of the titanium abutment
04
Bonding of the titanium shell to the aesthetic restorative material
05
Final inspection and delivery upon written prescription

Materials & Processes

Titanium

Always used in the gingival contact area and forms the thin patient-specific shell (bowl/housing) of the hybrid abutment.

Ano

Gold anodization

The gold-colored anodization of the titanium prevents show-through at the gum line; a non-toxic re-anodization is possible.

Cer

Ceramics

Ceramics are positioned as aesthetic restorative material inside or behind the titanium shell.

Pol

Polymers

Serve as aesthetic restorative material inside the titanium shell depending on the workflow.

3D-KM

3D-printed crown materials

Enable the combination of the EAP® Abutment with 3D-printed crowns in the digital workflow.

Locations

Hall in Tirol

Administration, manufacturing and contact address (Lorettostraße 26, 2nd and 3rd floor)

Lot size: One-off production: 1 piece per patient and prescription, no stock items
Materials: Titanium; ceramics; polymers; 3D-printed crown materials

Industries

Dental medicine / implantologyDental laboratoriesMedical devices (Regulation (EU) 2017/745 – MDR)Medical devices (Regulation (EU) 2017/745)

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Manufacture of patient-individual hybrid abutments (EAP® Abutment, thin titanium shellMedical technology manufacturing / abutment production	–	–	–	1 piece (no minimum order quantity) – 1 piece (one-off production per patient)	Titanium, Ceramics, Polymers, 3D-printed crown materials
Digital planning and STL-based manufacturingEngineering	–	–	–	–	Titanium
Anodization of the titanium abutment (gold-colored anodized, non-toxic re-anodization possible)Surface	–	–	–	–	Titanium
Milling of the titanium shell (titanium housing can be milled away if required – local reworking)Machining	–	–	–	–	Titanium
Polishing of the exposed titanium surface (local adjustment after recession, processing timeSurface	–	–	–	–	Titanium
Assembly/bonding: adhesive joint between titanium shell and aesthetic restorative materialJoining	–	–	–	–	Titanium, Ceramics, Polymers, 3D-printed crown materials
Manufacture of abutments upon written prescription (Custom-made Device under MDR Art. 2(3))Engineering	–	–	–	1 – 1 (manufacturing only upon written	Titanium

Additional services

Manufacture of patient-individual titanium abutments (Custom-made Device under MDR Art. 2(3))Digital workflow / STL-based manufacturingSubsequent adjustment and re-anodizationROBOTER implantology-compatible workflowsEAP Skills Academy (training, tutorials for dentists and dental technicians)Support of the EAP fast method (immediate impression after implantation, One-Abutment-One-Time)

Quality & Compliance

EAP® Abutments are manufactured as patient-specific Custom-made Devices under MDR Art. 2(3) exclusively upon written prescription; conformity documentation is carried out in accordance with Annex XIII of the MDR. Due to the Custom-made Device regulation, there is no CE marking; according to the manufacturer's information, no ISO certificates are specified.

Evidence	Hall in Tirol
MDR Custom-made Device (Art. 2(3))

History

2009
Start of scientific research according to the company