Ceramill Mind DRS

GUDID 04260521363305

ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings, veneers, bridges, pontics, provisionals, and bite splints via a 3D CAD tool. The design is based on suitable 3D scans of the patient’s dental anatomy produced by a compatible scanner. The software generates geometrical output of the design for manufacturing on compatible CAM systems. ChairsideCAD is intended to be used by trained professionals in dental practices and is not to be used for any purpose other than the design of dental restorations or bite splints, nor is it to be used for designing dental abutments.

exocad GmbH

Dental CAD/CAM system, chairside
Primary Device ID04260521363305
NIH Device Record Key96a36194-8728-46bc-ab0e-993eccd8c36b
Commercial Distribution Discontinuation2026-10-26
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramill Mind DRS
Version Model Number1.0
Company DUNS341575872
Company Nameexocad GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260521363305 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-03
Device Publish Date2021-10-26

Devices Manufactured by exocad GmbH

04260521363534 - AbutmentCAD2024-09-23 The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles a
04260521361035 - DentalDB2023-06-13 DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental labor
04260521363039 - ChairsideCAD2023-06-13 ChairsideCAD is a software device intended to support the design of dental restorations such as inlays, onlays, crowns, copings,
04260521361523 - DentalDB2023-02-24 DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental labor
04260521365026 - exoplan2023-02-24 exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the
04260521363527 - AbutmentCAD2022-08-09 The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles a
04260521361516 - DentalDB2022-05-17 DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dental labor
04260521365019 - exoplan2022-05-17 exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.