FDA.report

Condyloform II NFC plus 8er

Primary DI
D7076603320
Brand
Condyloform II NFC plus 8er
Company
IVOCLAR VIVADENT, INC.
Model
660332
Catalog number
660332
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
ELMDenture, plastic, teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7076603320PrimaryHIBCC0

GMDN Terms

TermDefinition
Ceramic artificial teethPrefabricated teeth made of ceramic (porcelain) for mounting on removable dentures or fixed partial dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, and sets of premolar and molar teeth, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods

Method

Regulatory Flags

DUNS number
176935203
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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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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