AbutmentCAD

GUDID 04260521363527

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.

exocad GmbH

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Primary Device ID04260521363527
NIH Device Record Keye98662ab-7871-4fa0-9a2c-0837f26cd241
Commercial Distribution Discontinuation2027-08-02
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutmentCAD
Version Model Number3.1
Company DUNS341575872
Company Nameexocad GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104260521363527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNPDental Abutment Design Software For Dental Laboratory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [AbutmentCAD]

04260521363510The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially
04260521363527The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially

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