FDA.report

smile design

Primary DI
D7076015041
Brand
smile design
Company
IVOCLAR VIVADENT, INC.
Model
601504
Catalog number
601504
Published
2020-08-04
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
true

Related Records

Product Codes

CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7076015041PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis bite verification deviceA device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production. It is affixed with a dental prosthetic screw or dental prosthetic screw analogu(also known as guide pin). This is a single-use device.

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
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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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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