FDA.reportPublic FDA data

UltraPrint-Dental Denture Teeth UV

Primary DI
06971437940099
Brand
UltraPrint-Dental Denture Teeth UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
1.0
Device description
500g, UltraPrint-Dental Denture Teeth UV-B1
Published
2021-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06971437940099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971437940099069714379400996971437940099

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
418561545
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971437944325UltraPrint Hard Splint UV2.02026-03-26
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
06971437942192UltraPrint-Dental Denture UV2.02026-03-04
06971437942208UltraPrint-Dental Denture UV2.02026-03-04
06971437942215UltraPrint-Dental Denture UV2.02026-03-04
06971437942222UltraPrint-Dental Denture UV2.02026-03-04
06971437942239UltraPrint-Dental Denture UV2.02026-03-04
06971437942246UltraPrint-Dental Denture UV2.02026-03-04
06971437942253UltraPrint-Dental Denture UV2.02026-03-04
06971437942260UltraPrint-Dental Denture UV2.02026-03-04
06971437942277UltraPrint-Dental Denture UV2.02026-03-04
06971437942284UltraPrint-Dental Denture UV2.02026-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
08056865154466ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155647ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155654ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155661ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17