FDA.reportPublic FDA data

AbutmentCAD

Primary DI
04260521363541
Brand
AbutmentCAD
Company
exocad GmbH
Model
3.3
Device description
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Published
2025-10-08
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
PNPDental Abutment Design Software For Dental Laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNPDental Abutment Design Software For Dental LaboratoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193352000AbutmentCADExocad GmbH2021-07-21PNP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260521363541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260521363541042605213635414260521363541

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, chairsideAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.

Regulatory Flags#

DUNS number
341575872
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260521363633Ceramill M-Plant3.32026-02-02
04260521363534AbutmentCAD3.22024-01-10
04260521361509DentalDB2.3 (exoplan)2021-01-08
04260521363312Ceramill Mind DRS3.12025-01-24
04260521363619Ceramill M-Plant3.12025-01-24
04260521363015ChairsideCAD2.3 Matera2019-11-12
04260521361011DentalDB2.3 (ChairsideCAD)2021-01-08
04260521361035DentalDB3.1 (ChairsideCAD)2023-06-05
04260521363039ChairsideCAD3.1 Rijeka2023-06-05
04260521363527AbutmentCAD3.12022-08-01
04260521363022ChairsideCAD3.0 Galway2021-10-26
04260521363305Ceramill Mind DRS1.02021-10-26
04260521363510AbutmentCAD3.02021-10-26
04260521363008ChairsideCAD2.12018-02-20
04260521361523DentalDB3.1 (exoplan)2023-02-16
04260521365026exoplan3.1 Rijeka2023-02-16
04260521361004DentalDB2.12018-02-20
04260521361516DentalDB3.0 (exoplan)2022-05-09
04260521361028DentalDB3.0 (ChairsideCAD)2021-10-26
04260521365019exoplan3.0 Galway2022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435566602719IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566602764IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566601101IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-07-14
08435566609091IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609107IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609114IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609121IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609138IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609145IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609152IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609169IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609176IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609183IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609190IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609589IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609596IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609602IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609619IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609626IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609633IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566609640IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610691IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610707IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610714IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610721IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610776IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610783IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610790IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566610806IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-17
08435566603839IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2025-01-16