FDA.reportPublic FDA data

BONARTIC CT

Primary DI
E1995481151
Brand
BONARTIC CT
Company
Candulor AG
Model
548115
Catalog number
548115
Published
2016-09-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELLTEETH, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELLTeeth, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E1995481151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
480467422
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630813462165TCR Mono7561987561982025-05-20
07630813462202TCR Mono7562027562022025-05-20
07630813462226TCR Mono7562047562042025-05-20
07630813462233TCR Mono7562057562052025-05-20
07630813462240TCR Multi7562167562162025-05-20
07630813462264TCR Multi7562187562182025-05-20
07630813462271TCR Multi7562197562192025-05-20
07630813462295TCR Multi7562217562212025-05-20
07630813462301TCR Multi7562227562222025-05-20
07630813462158TCR Mono7561977561972025-05-20
07630813462172TCR Mono7561997561992025-05-20
07630813462189TCR Mono7562007562002025-05-20
07630813462196TCR Mono7562017562012025-05-20
07630813462219TCR Mono7562037562032025-05-20
07630813462257TCR Multi7562177562172025-05-20
07630813462288TCR Multi7562207562202025-05-20
07630813462318TCR Multi7562237562232025-05-20
07630813462325TCR Multi7562247562242025-05-20
07630813439709XPLEX7111757111752022-11-14
07630813439730XPLEX7109127109122022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979878380078Jiahong dental labShenzhen Jiahong Dental Technology Co.,Ltd.ELL2026-04-03
06975409640055ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640062ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409640079ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
06975409641007ZrcoopHangzhou Thales Medtech Co., Ltd.ELL2025-01-03
E23561010VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23561020VINTAGESHOFU DENTAL CORPORATIONELL2021-02-03
E23566850VINTAGE MARGINSHOFU DENTAL CORPORATIONELL2021-02-03
E23569010VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569040VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
E23569050VINTAGE OPALSHOFU DENTAL CORPORATIONELL2021-02-03
07332747179569NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179576NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179583NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179590NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179606NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179613NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179620NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179637NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179644NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179651NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179668NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179675NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179682NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179699NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179705NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179712NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179729NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179736NobelProcera®Nobel Biocare ABELL2020-12-11
07332747179743NobelProcera®Nobel Biocare ABELL2020-12-11