FDA.reportPublic FDA data

UltraPrint-Dental Denture Teeth UV

Primary DI
06971437940662
Brand
UltraPrint-Dental Denture Teeth UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
1.0
Device description
250g, UltraPrint-Dental Denture Teeth UV-B2
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
06971437940662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971437940662069714379406626971437940662

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
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

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00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
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08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIPZY2026-08-25
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