exoplan 3.0 Galway

Organization name

exocad GmbH

SRN

DE-MF-000007341

Manufacturer status

Active

Primary placement in Germany; available across 20 countries total.

Trade name

exoplan 3.0 Galway

UDI-DI code

04260521365019

Basic UDI-DI

426052136EXOPLAN21A6

Reference / catalog number

4260521365019

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.

Additional information URL

https://www.exocad.com/

Clinical sizes

No clinical sizes registered for this device.

• Q010399SURGICAL DENTAL DEVICES - OTHER

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