FDA.reportPublic FDA data

Tooth Shade Resin Material

Primary DI
06941382277366
Brand
Tooth Shade Resin Material
Company
Liaoning Upcera Co.,Ltd.
Model
LT-M-C2-D(98-10)
Published
2024-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06941382277366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06941382277366069413822773666941382277366

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
548214192
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942201747329FLNT TempTD-M-C4 D98-162026-05-26
06942201747398FLNT TempTD-S-A1 D98-182026-05-26
06942201747404FLNT TempTD-S-B1 D98-182026-05-26
06942201747497FLNT TempTD-M-A2 D98-182026-05-26
06942201747589FLNT TempTD-S-BL4 D98-202026-05-26
06942201747596FLNT TempTD-S-A4 D98-202026-05-26
06942201747688FLNT TempTD-M-A1 D98-202026-05-26
06942201747695FLNT TempTD-M-B1 D98-202026-05-26
06942201747701FLNT TempTD-M-C2 D98-202026-05-26
06942201747886FLNT TempTD-M-A4 D98-222026-05-26
06942201747978FLNT TempTD-S-A3 D98-252026-05-26
06942201746728FLNT TempTD-M-A1 D98-102026-05-22
06942201747015FLNT TempTD-S-A3 D98-142026-05-22
06942201747114FLNT TempTD-M-A3.5 D98-142026-05-22
06942201747190FLNT TempTD-S-BL1 D98-162026-05-22
06942201747206FLNT TempTD-S-A2 D98-162026-05-22
06942201747305FLNT TempTD-M-A3 D98-162026-05-22
06941382291010Gradual Dental Zirconia BlankGT(F)P2-M-BL2 D98-252026-04-22
06941382291027Gradual Dental Zirconia BlankGT(F)P2-M-BL3 D98-122026-04-22
06941382291034Gradual Dental Zirconia BlankGT(F)P2-M-BL3 D98-142026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28