FDA.reportPublic FDA data

UltraPrint-Dental Denture Teeth UV

Primary DI
06971437940488
Brand
UltraPrint-Dental Denture Teeth UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
1.0
Device description
160g, UltraPrint-Dental Denture Teeth UV-A3.5
Published
2022-10-24
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
false

Product Codes#

Code, Name table
CodeName
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971437940488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971437940488069714379404886971437940488

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Regulatory Flags#

DUNS number
418561545
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971437943618UltraPrint Flexible Denture UV1.02026-08-27
06971437943625UltraPrint Flexible Denture UV1.02026-08-27
06971437943649UltraPrint Flexible Denture UV1.02026-08-27
06971437943700UltraPrint Flexible Denture UV1.02026-08-27
06971437943748UltraPrint Flexible Denture UV1.02026-08-27
06971437942314UltraPrint Denture UV2.02026-03-05
06971437942321UltraPrint Denture UV2.02026-03-05
06971437942338UltraPrint Denture UV2.02026-03-05
06971437942352UltraPrint Denture UV2.02026-03-05
06971437942376UltraPrint Denture UV2.02026-03-05
06971437942383UltraPrint Denture UV2.02026-03-05
06971437942390UltraPrint Denture UV2.02026-03-05
06971437942406UltraPrint Denture UV2.02026-03-05
06971437942413UltraPrint Denture UV2.02026-03-05
06971437941249UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437941256UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437941263UltraPrint-Dental Surgical Guide UV1.02022-12-07
06971437940457UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940464UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940471UltraPrint-Dental Denture Teeth UV1.02022-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.PZY2026-05-29
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08