FDA.report

R2i3

Primary DI
08809985650987
Brand
R2i3
Company
Megagen Implant Co. Ltd
Model
IOS-11
Catalog number
IOS-11
Published
2024-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications

CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809985650987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809985650987088099856509878809985650987

GMDN Terms

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

Regulatory Flags

DUNS number
687388178
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08806388221875Intermezzo FixtureIMTI1615IMTI16152015-06-25
08806388221967Intermezzo FixtureIMTI2510IMTI25102015-06-25
08806388222056Intermezzo FixtureIMTI3115IMTI31152015-06-25
08806388207381Impression CopingAMIC3506SAMIC3506S2026-02-20
08806388207398Impression CopingAMIC3510MAMIC3510M2026-02-20
08806388207404Impression CopingAMIC3514LAMIC3514L2026-02-20

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