FDA.reportPublic FDA data

Bioform® VF Porcelain Anteriors

Primary DI
D00113153LB91V0
Brand
Bioform® VF Porcelain Anteriors
Company
Dentsply International Inc.
Model
B91 L V
Catalog number
13153
Published
2016-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
D00113153LB91V0PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentspl
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags#

DUNS number
606173334
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

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