FDA.reportPublic FDA data

AbutmentCAD

Primary DI
04260521363510
Brand
AbutmentCAD
Company
exocad GmbH
Model
3.0
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
2021-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04260521363510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260521363510042605213635104260521363510

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.

Regulatory Flags#

DUNS number
341575872
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
04260521365019exoplan3.0 Galway2022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncPNP2026-03-16
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