FDA.reportPublic FDA data

UltraPrint-Dental Surgical Guide UV

Primary DI
06971437941263
Brand
UltraPrint-Dental Surgical Guide UV
Company
GUANGZHOU HEYGEARS IMC.INC
Model
1.0
Device description
UltraPrint-Dental Surgical Guide UV, 1000g/bottle
Published
2022-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971437941263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971437941263069714379412636971437941263

GMDN Terms#

Term, Definition table
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.

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
06971437940457UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940464UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940471UltraPrint-Dental Denture Teeth UV1.02022-10-24
06971437940488UltraPrint-Dental Denture Teeth UV1.02022-10-24

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