FDA.reportPublic FDA data

fastdesign.io

Primary DI
D745701181MIL046710150
Brand
fastdesign.io
Company
Prismatik Dentalcraft, Inc
Model
70-1181-MIL0467
Catalog number
70-1181-MIL0467
Device description
fastdesign.io™ (including two-piece hybrid abutments and dental restorations design)
Published
2026-03-16
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

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701181MIL046710150PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
022761689
Device count
1
DM exempt
false
Premarket exempt
false
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
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701072PRC00010Inclusive70-1072-PRC000170-1072-PRC00012015-10-24
D745701072PRC00580Inclusive70-1072-PRC005870-1072-PRC00582015-10-24
D745701173COM00040Inclusive70-1173-COM000470-1173-COM00042016-10-07
D745701122SHS01451Obsidian70-1122-SHS014570-1122-SHS01452016-09-23
D745701182BZE05590BruxZir®70-1182-BZE055970-1182-BZE05592026-07-07
D745701182BZE05600BruxZir®70-1182-BZE056070-1182-BZE05602026-07-07
D745701182BZE05610BruxZir®70-1182-BZE056170-1182-BZE05612026-07-07
D745701182BZE05640BruxZir®70-1182-BZE056470-1182-BZE05642026-07-07
D745701182BZE05760BruxZir®70-1182-BZE057670-1182-BZE05762026-07-07
D745701182BZE05770BruxZir®70-1182-BZE057770-1182-BZE05772026-07-07
D745701182BZE05780BruxZir®70-1182-BZE057870-1182-BZE05782026-07-07
D745701182BZE05790BruxZir®70-1182-BZE057970-1182-BZE05792026-07-07
D745701182BZE05820BruxZir®70-1182-BZE058270-1182-BZE05822026-07-07
D745701182BZE05940BruxZir®70-1182-BZE059470-1182-BZE05942026-07-07
D745701182BZE05950BruxZir®70-1182-BZE059570-1182-BZE05952026-07-07
D745701182BZE05960BruxZir®70-1182-BZE059670-1182-BZE05962026-07-07
D745701182BZE05970BruxZir®70-1182-BZE059770-1182-BZE05972026-07-07
D745701182BZE06000BruxZir®70-1182-BZE060070-1182-BZE06002026-07-07
D745701182BZE06120BruxZir®70-1182-BZE061270-1182-BZE06122026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668907712Single use sleeve Primescan BoxSIRONA Dental Systems GmbHNOF2026-09-22
00860016329201OriOri IncNOF2026-08-21
06975456120005UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-08-19
04262352354897DS Core RestoZetta25 AGNOF2026-08-14
00693856000340DEXIS Imprevo SLIM TIPDental Imaging Technologies CorporationNOF2026-08-07
06942799000820Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000837Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000844Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000851Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06970163088693SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-07-21
08800019601081LS-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601128LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601135LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
06430035421077Planmeca OnyxPlanmeca OyNOF2026-06-24
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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