FDA.report

BONARTIC CT

Primary DI
E1995481071
Brand
BONARTIC CT
Company
Candulor AG
Model
548107
Catalog number
548107
Published
2016-09-29
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
true

Related Records

Product Codes

CodeName
ELLTEETH, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
ELLTeeth, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E1995481071PrimaryHIBCC0

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
480467422
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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07630813462219TCR Mono7562037562032025-05-20
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07630813439242Candulor Preference5784235784232023-11-16
07630813439259Candulor Preference5784225784222023-11-16

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