FDA.reportPublic FDA data

SprintRay Foundation Scanner Tip (2pcs)

Primary DI
06973993443229
Brand
SprintRay Foundation Scanner Tip (2pcs)
Company
Alliedstar Medical Equipment Co., Ltd.
Model
TP301
Catalog number
6583660
Published
2026-10-23
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
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
06973993441669Direct MarkingGS10
06973993443229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973993441669069739934416696973993441669
06973993443229069739934432296973993443229

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
true
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
06973993440440SprintRay Foundation HandpieceS300W65836592026-10-23
06973993442758SprintRay Foundation ScannerS300W65836432026-10-23
06973993443212SprintRay Foundation Charging DockCHR 300W65836582026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973993440440SprintRay Foundation HandpieceAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06973993442758SprintRay Foundation ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06973993443212SprintRay Foundation Charging DockAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
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