FDA.reportPublic FDA data

UltraPrint Surgical Guide UV

Primary DI
06971437944264
Brand
UltraPrint Surgical Guide UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
1.0
Device description
UltraPrint Surgical Guide UV, 500g/bottle,Transparent
Published
2026-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971437944264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971437944264069714379442646971437944264

GMDN Terms

TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
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
06971437942291UltraPrint-Dental Denture UV2.02026-03-04

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