FDA.reportPublic FDA data

FastMap

Primary DI
00817421022883
Brand
FastMap
Company
XNAV TECHNOLOGIES LLC
Model
P012003
Device description
FASTMAP USER MANUAL, ENGLISH
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00817421022883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817421022883008174210228838174210228830817421022883

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, laboratoryAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
026096247
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817421023668X-GuideP0112652026-10-14
00817421023675X-GuideP0112662026-10-14
00817421023682X-GuideP0112682026-10-14
00817421023699X-GuideP0112692026-10-14
00817421023705X-GuideP0112712026-10-14
00817421023712X-GuideP0112722026-10-14
00817421023729X-GuideP0116932026-10-14
00817421023736X-GuideP0116942026-10-14
00817421023743X-GuideP0116962026-10-14
00817421023750X-GuideP0116972026-10-14
00817421023767X-GuideP0121262026-10-14
00817421023774X-GuideP0121272026-10-14
00817421023781X-GuideP0121282026-10-14
00817421023798X-GuideP0121292026-10-14
00817421023323X-GuideP0115582026-10-13
00817421023354X-GUIDEP0115482026-10-13
00817421023545X-GUIDEP0123612026-10-13
00817421023552X-GUIDEP0115432026-10-13
00817421023569X-GUIDEP0115442026-10-13
00817421023576X-GUIDEP0115452026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942799001117SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163080369SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163080406SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089904SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089911SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089959SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
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
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
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