FDA.report

Tooth Shade Resin Material

Primary DI
06941382275720
Brand
Tooth Shade Resin Material
Company
Liaoning Upcera Co.,Ltd.
Model
HT-S-C1-D(98-12)
Published
2023-10-18
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
true

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin
EIHPowder, Porcelain

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EIHPowder, PorcelainDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06941382275720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06941382275720069413822757206941382275720

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
548214192
Device count
1
DM exempt
false
Premarket exempt
false
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

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06941382286740Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-182026-03-20
06941382286757Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-202026-03-20
06941382286764Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-222026-03-20
06941382286771Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-252026-03-20
06941382286788Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-122026-03-20
06941382286795Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-142026-03-20
06941382286801Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-182026-03-20
06941382286818Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-202026-03-20
06941382286825Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-222026-03-20
06941382286832Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D98-252026-03-20
06941382286849Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-122026-03-20
06941382286856Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-142026-03-20
06941382286863Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-162026-03-20
06941382286870Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-182026-03-20
06941382286887Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-202026-03-20
06941382286894Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-222026-03-20
06941382286900Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D100-252026-03-20
06941382286917Gradual Dental Zirconia BlankGT(F)P1-M-BL3 D16-162026-03-20
06941382286924Gradual Dental Zirconia BlankGT(F)P1-M-BL3 D20-202026-03-20
06941382286931Gradual Dental Zirconia BlankGT(F)P1-M-BL3 D70-122026-03-20

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