FDA.report

1M ixing TIps short15 Lab Refill

Primary DI
D7076668281
Brand
1M ixing TIps short15 Lab Refill
Company
IVOCLAR VIVADENT, INC.
Model
666828
Catalog number
666828
Device description
1M ixing TIps short15 Lab Refill
Published
2020-11-11
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
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7076668281PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176935203
Device count
1
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

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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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