FDA.reportPublic FDA data

MicronMapper EVO

Primary DI
07540209956263
Brand
MicronMapper EVO
Company
Claronav Inc
Model
955-MME-ESSM-ASY
Device description
"MicronMapper EVO (Full System), including: MicronMapper Software and MicronMapper EVO Scan Bodies. To be used in combination with the Navident System (""EVO"" variant only)"
Published
2024-05-07
Public version status
Update
Distribution status
Not 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
07540209956263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540209956263075402099562637540209956263

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
207008769
Device count
1
Premarket exempt
true
Manufacturing date on label
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
07540209957604MicronMapper950-MM1-SLOC-BDY950-MM1-SLOC-BDY2026-02-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942799001193SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
06942799001209SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
06942799001216SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
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
06973993443229SprintRay Foundation Scanner Tip (2pcs)Alliedstar 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