FDA.reportPublic FDA data

Ceramill M-Plant

Primary DI
04260521363619
Brand
Ceramill M-Plant
Company
exocad GmbH
Model
3.1
Device description
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant 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
2025-01-24
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
04260521363619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260521363619042605213636194260521363619

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.

Sterilization Methods#

Method table
Method

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
04260521363541AbutmentCAD3.32025-10-08
04260521363312Ceramill Mind DRS3.12025-01-24
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