FDA.reportPublic FDA data

exoplan

Primary DI
04260521365002
Brand
exoplan
Company
exocad GmbH
Model
2.3 Matera
Device 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.
Published
2019-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183458000exoplan 2.3Exocad GmbH2019-08-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260521365002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260521365002042605213650024260521365002

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Regulatory Flags#

DUNS number
341575872
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260521361028DentalDB3.0 (ChairsideCAD)2021-10-26
04260521363022ChairsideCAD3.0 Galway2021-10-26
04260521363305Ceramill Mind DRS1.02021-10-26
04260521363510AbutmentCAD3.02021-10-26
04260521361035DentalDB3.1 (ChairsideCAD)2023-06-05
04260521361523DentalDB3.1 (exoplan)2023-02-16
04260521361516DentalDB3.0 (exoplan)2022-05-09
04260521361011DentalDB2.3 (ChairsideCAD)2021-01-08
04260521361509DentalDB2.3 (exoplan)2021-01-08
04260521361004DentalDB2.12018-02-20
04260521363633Ceramill M-Plant3.32026-02-02
04260521363534AbutmentCAD3.22024-01-10
04260521363541AbutmentCAD3.32025-10-08
04260521363312Ceramill Mind DRS3.12025-01-24
04260521363619Ceramill M-Plant3.12025-01-24
04260521363015ChairsideCAD2.3 Matera2019-11-12
04260521363039ChairsideCAD3.1 Rijeka2023-06-05
04260521363527AbutmentCAD3.12022-08-01
04260521363008ChairsideCAD2.12018-02-20
04260521365026exoplan3.1 Rijeka2023-02-16

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