FDA.reportPublic FDA data

i900 Series Single Use Tip

Primary DI
08800026700876
Brand
i900 Series Single Use Tip
Company
Medit Corp.
Model
MO1-ST1
Device description
i900 Series Single-Use Tip
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
18800026700873PackageGS110In Commercial Distribution
28800026700870PackageGS15In Commercial Distribution
08800026700876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880002670087318800026700873
2880002670087028800026700870
08800026700876088000267008768800026700876

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.8 KiloPascal1.1 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius28 Degrees Celsius
Storage Environment Atmospheric Pressure0.8 KiloPascal1.1 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82221939600support@medit.com

Regulatory Flags#

DUNS number
688800085
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026700890Medit AuraVueMA-AAV2026-05-11
08800026700760Medit Link ExpressML-EXP0012026-04-28
08800026700883Medit Link ExpressML-EXP0022026-04-28
08800026700302Reusable Tip (Medium)MO1-RTM2024-04-09
08800026700319 Reusable Tip (Large) MO1-RTL2024-04-09
08800026700395 Reusable Tip (Small)MO1-RTS2024-04-09
18800026700873i900 Series Single Use TipMO1-ST12026-02-03
08800026700630i900 MobilityMO3-i900M2025-07-25
08800026700869Medit Orthodontic Suite2.02025-05-29
08800026700623i900 classicMO4-i900c2025-05-22
08800026700203Medit ClinicCADMedit ClinicCAD2024-06-21
08800026700159Medit DesignMedit Design2023-08-02
08800026700166Medit OrthoSimulationMedit OrthoSimulation2023-08-02
08800026700173Medit SplintsMedit Splints2023-08-02
08800026700180Medit TemporariesMedit Temporaries2023-08-02
08800026700289i900MO1-i900 2024-04-09
08800026700296Handpiece CoverMO1-HC12024-04-09
08800026700326 Calibration Tool MO1-CT12024-04-09
08800026700340Desktop CradleMO1-DC12024-04-09
08800026700357Wall Mount HolderMO1-WH12024-04-09

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
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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