FDA.report

Tooth Shade Resin Material

Primary DI
06942201719104
Brand
Tooth Shade Resin Material
Company
Liaoning Upcera Co.,Ltd.
Model
LT-S-W3-D(98-12)
Published
2025-03-18
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

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06942201719104PrimaryGS10

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

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

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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
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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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