FDA.reportPublic FDA data

MicronMapper

Primary DI
07540209957604
Brand
MicronMapper
Company
Claronav Inc
Model
950-MM1-SLOC-BDY
Catalog number
950-MM1-SLOC-BDY
Device description
MicronMapper Locator Scan Bodies, Set 40-45
Published
2026-02-10
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
07540209957604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209957604075402099576047540209957604

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
207008769
Device count
1
DM exempt
true
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
07540209957482MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-02026-02-10
07540209957499MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-12026-02-10
07540209957505MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-22026-02-10
07540209957512MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-32026-02-10
07540209957529MicronMapper955-MM1-SS16-BDY955-MM1-SS16-BDY-42026-02-10
07540209957536MicronMapper955-MME-SS16-BDY955-MME-SS16-BDY2026-02-10
07540209957543MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-02026-02-10
07540209957550MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-12026-02-10
07540209957567MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-22026-02-10
07540209957574MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-32026-02-10
07540209957581MicronMapper955-MM1-SMNI-BDY955-MM1-SMNI-BDY-42026-02-10
07540209957611MicronMapper950-MM1-SS14-BSE950-MM1-SS14-BSE-82026-02-10
07540209957628MicronMapper950-MM1-SS14-BSE950-MM1-SS14-BSE-162026-02-10
07540209957635MicronMapper950-MM1-SS16-BSE950-MM1-SS16-BSE-82026-02-10
07540209957642MicronMapper950-MM1-SS16-BSE950-MM1-SS16-BSE-162026-02-10
07540209957659MicronMapper950-MM1-SMNI-BSE950-MM1-SMNI-BSE2026-02-10
07540209957666MicronMapper EVO955-MME-ESSM-ASY955-MME-ESSM-ASY-C2026-02-10
07540209956584MicronMapper955-MM1-SPLT-BDY955-MM1-SPLT-BDY-12025-03-03
07540209956591MicronMapper955-MM1-SPLT-BDY955-MM1-SPLT-BDY-22025-03-03
07540209956607MicronMapper955-MM1-SPLT-BDY955-MM1-SPLT-BDY-32025-03-03

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
07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10
07540209957659MicronMapperClaronav IncNOF2026-02-10