FDA.report

Harmony 2

Primary DI
D7076435960
Brand
Harmony 2
Company
IVOCLAR VIVADENT, INC.
Model
643596
Catalog number
643596
Device description
Harmony 2 100g
Published
2018-10-29
Public version status
Update
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
EJSALLOY, OTHER NOBLE METAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJSAlloy, Other Noble MetalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7076435960PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176935203
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D7076464601Virtual XD6464606464602023-11-09
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D7076464621Virtual XD6464626464622023-11-09
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D7076464681Virtual XD6464686464682023-11-09
D7076464691Virtual XD6464696464692023-11-09
D7077563420Vivastyle7563427563422023-11-02

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