FDA.report

Odyssey

Primary DI
D7075790390
Brand
Odyssey
Company
IVOCLAR VIVADENT, INC.
Model
579039
Catalog number
579039
Published
2017-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7075790390PrimaryHIBCC0
D7075790391Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176935203
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
D707562826AN0Virtual562826AN562826AN2017-04-07
D707562852AN0Virtual562852AN562852AN2017-04-07
D707562853AN0Virtual562853AN562853AN2017-04-07
D707562854AN0Virtual562854AN562854AN2017-04-07
D707562855AN0Virtual562855AN562855AN2017-04-07
D707562858AN0Virtual562858AN562858AN2017-04-07
D707562859AN0Virtual562859AN562859AN2017-04-07
D707562862AN0Virtual562862AN562862AN2017-04-07
D707573527EN0Virtual573527AN573527AN2017-04-07
D707NA60501410ValiantNA6050141NA60501412017-01-27
D7076464481Virtual XD6464486464482023-11-09
D7076464491Virtual XD6464496464492023-11-09
D7076464591Virtual XD6464596464592023-11-09
D7076464601Virtual XD6464606464602023-11-09
D7076464611Virtual XD6464616464612023-11-09
D7076464621Virtual XD6464626464622023-11-09
D7076464671Virtual XD6464676464672023-11-09
D7076464681Virtual XD6464686464682023-11-09
D7076464691Virtual XD6464696464692023-11-09
D7077563420Vivastyle7563427563422023-11-02

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