FDA.reportPublic FDA data

Intraoral Scanner

Primary DI
06977274260260
Brand
Intraoral Scanner
Company
Changsha Honchon Technology Co., LTD
Model
HCE-IS-300
Published
2025-08-31
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
06977274260260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977274260260069772742602606977274260260

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
550050296
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977274260253Intraoral ScannerHCE-IS-1302025-08-31
06977274260277Intraoral ScannerHCE-IS-5002025-08-31
06977274260284Intraoral ScannerHCE-IS-8002025-08-31
06977274260017Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHS2024-03-31
06977274260024Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT2024-03-31
06977274260031Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT-C2024-03-31
06977274260048Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHT-Plus2024-03-31
06977274260055Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHTP-C2024-03-31
06977274260062Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST2024-03-31
06977274260079Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-C2024-03-31
06977274260086Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-Plus2024-03-31
06977274260093Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSTP-C2024-03-31
06977274260109Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankST-ML2024-03-31
06977274260116Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT2024-03-31
06977274260123Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-C2024-03-31
06977274260130Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSHT-ML2024-03-31
06977274260147Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-ML2024-03-31
06977274260154Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-Plus-ML2024-03-31
06977274260161Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank3D-Pro-ML2024-03-31
06977274260178Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank4D-ML2024-03-31

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
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