exoplan

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 4260521365019Model 3.0

by exocad GmbH

Identity

Trade Name: exoplan EUDAMEDFDA UDI
exoplan 3.0 Galway EUDAMED
Generic Name: Dental treatment application software FDA UDI
Device Name: exoplan EUDAMED
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. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. 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. FDA UDI
Model / Reference: 3.0 EUDAMED
4260521365019 EUDAMED
3.0 Galway FDA UDI
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. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260521365019 EUDAMEDFDA UDI
Basic UDI-DI: B-04260521365019 EUDAMED
426052136EXOPLAN21A6 EUDAMED
Direct Marketing DI: 04260521365019 EUDAMED
FDA Product Code: LLZ FDA UDI
EMDN Code: Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
GMDN Term: Dental treatment application software FDA UDI

Classification

Device Class: Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

exoplan by exocad GmbH — Class I — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K213302	Class I	Active
EUDAMED	European Union	CE/MDR	B-04260521365019	Class I	Active
EUDAMED	European Union	CE/MDD	B-04260521365019	Class I	Active

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Manufacturer

Manufacturer: exocad GmbH
EUDAMED SRN: DE-MF-000007341

Sources (4)

EUDAMED f842bc3d-97a1-4a32-acba-7b3031684e29 61 fields · synced Jul 28, 2026
EUDAMED 7491cb46-8919-405a-9254-5583e500da03 61 fields · synced May 17, 2026
FDA UDI e8f67f78-6273-483d-9517-7fa08b12ca50 33 fields · synced May 30, 2026
FDA 510(k) K213302 1 fields · synced May 18, 2026