fastdesign.io 70-1181-MIL0016

GUDID D745701181MIL001610150

fastdesign.io™ (dental restorations design)

Prismatik Dentalcraft, Inc

CAD/CAM software
Primary Device IDD745701181MIL001610150
NIH Device Record Key8f5ad246-6a00-4337-88d2-8640594d56be
Commercial Distribution StatusIn Commercial Distribution
Brand Namefastdesign.io
Version Model Number70-1181-MIL0016
Catalog Number70-1181-MIL0016
Company DUNS022761689
Company NamePrismatik Dentalcraft, Inc
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 Datetrue
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
HIBCCD745701181MIL001610150 [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 Date2026-03-24
Device Publish Date2026-03-16

On-Brand Devices [fastdesign.io]

D745701181MIL046710150fastdesign.io™ (including two-piece hybrid abutments and dental restorations design)
D745701181MIL001610150fastdesign.io™ (dental restorations design)

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