FDA.reportPublic FDA data

i900 Series Single Use Tip

Primary DI
18800026700873
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
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688800085
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08800026700876i900 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
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07540209957581MicronMapperClaronav IncNOF2026-02-10
07540209957604MicronMapperClaronav IncNOF2026-02-10
07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10