FDA.reportPublic FDA data

NeoScan

Primary DI
26973993441069
Brand
NeoScan
Company
Alliedstar Medical Equipment Co., Ltd.
Model
TP103N
Catalog number
91013
Device description
Intraoral scanner S tip
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

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
26973993441069PackageGS12In Commercial Distribution
06973993441065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697399344106926973993441069
06973993441065069739934410656973993441065

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral optical scanning systemAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
703541803
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973993442499Intraoral ScannerST 200EST6583202H2026-04-20
06973993444059AlliedstarDIP-A65835712026-02-17
16973993444056AlliedstarDIP-A65835712026-02-17
06973993440785AlliedstarAS 200E65832172025-12-11
06973993440808AlliedstarAS 26065832432025-12-11
06973993441119AlliedstarLi-18650-3.6V 3400mAh-PCM-Cap65832212025-12-11
06973993441522Alliedstar/65832442025-12-11
06973993441539Alliedstar/65832452025-12-11
06973993441546Alliedstar/65832462025-12-11
06973993441775AlliedstarCHR 200E65832032025-12-11
06973993442307AlliedstarAS 200E65833802025-12-11
06973993442314AlliedstarAS 200E65833862025-12-11
06973993442765AlliedstarAS 200E65832022025-12-11
06973993442796AlliedstarAS 26065832072025-12-11
06973993442819AlliedstarAS 26065832862025-12-11
06973993442826AlliedstarAS 26065833822025-12-11
06973993442833AlliedstarAS 26065833882025-12-11
16973993441116AlliedstarLi-18650-3.6V 3400mAh-PCM-Cap65832312025-12-11
06973993441942Dandy VisionTPDI1L65835692025-10-27
06973993441959Dandy VisionTPDI1S65835702025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
07540209957482MicronMapperClaronav IncNOF2026-02-10
07540209957499MicronMapperClaronav IncNOF2026-02-10
07540209957505MicronMapperClaronav IncNOF2026-02-10
07540209957512MicronMapperClaronav IncNOF2026-02-10
07540209957529MicronMapperClaronav IncNOF2026-02-10
07540209957536MicronMapperClaronav IncNOF2026-02-10
07540209957543MicronMapperClaronav IncNOF2026-02-10
07540209957550MicronMapperClaronav IncNOF2026-02-10
07540209957567MicronMapperClaronav IncNOF2026-02-10
07540209957574MicronMapperClaronav IncNOF2026-02-10
07540209957581MicronMapperClaronav IncNOF2026-02-10
07540209957604MicronMapperClaronav IncNOF2026-02-10
07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10