FDA.reportPublic FDA data

fastdesign.io

Primary DI
D745701181MIL00160
Brand
fastdesign.io
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1181-MIL0016
Catalog number
70-1181-MIL0016
Device description
fastmill.io system (fastdesign.io computer + fastmill.io)
Published
2018-10-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOFSystem, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701181MIL00160PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
021228671
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
D745701197FTD00010FinalTouch70-1197-FTD000170-1197-FTD00012022-09-14
D745701047COM00580Inclusive70-1047-COM005870-1047-COM00582015-10-24
D745701155BXA00010BruxZir70-1155-BXA000170-1155-BXA00012016-09-23
D745701155BXA00030BruxZir70-1155-BXA000370-1155-BXA00032016-09-23
D745701155BXA00040BruxZir70-1155-BXA000470-1155-BXA00042016-09-23
D745701155BXA00050BruxZir70-1155-BXA000570-1155-BXA00052016-09-23
D745701155BXA00060BruxZir70-1155-BXA000670-1155-BXA00062016-09-23
D745701155BXA00070BruxZir70-1155-BXA000770-1155-BXA00072016-09-23
D745701155BXA00080BruxZir70-1155-BXA000870-1155-BXA00082016-09-23
D745701155BXA00090BruxZir70-1155-BXA000970-1155-BXA00092016-09-23
D745701155BXA00100BruxZir70-1155-BXA001070-1155-BXA00102016-09-23
D745701155BXA00110BruxZir70-1155-BXA001170-1155-BXA00112016-09-23
D745701155BXA00120BruxZir70-1155-BXA001270-1155-BXA00122016-09-23
D745701155BXA00140BruxZir70-1155-BXA001470-1155-BXA00142016-09-23
D745701155BXA00150BruxZir70-1155-BXA001570-1155-BXA00152016-09-23
D745701155BXA00160BruxZir70-1155-BXA001670-1155-BXA00162016-09-23
D745701155BXA00170BruxZir70-1155-BXA001770-1155-BXA00172016-09-23
D745701155BXA00190BruxZir70-1155-BXA001970-1155-BXA00192016-09-23
D745701155BXA00210BruxZir70-1155-BXA002170-1155-BXA00212016-09-23
D745701155BXA00220BruxZir70-1155-BXA002270-1155-BXA00222016-09-23

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06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
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08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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