FDA.reportPublic FDA data

Tooth Shade Resin Material

Primary DI
06942201702502
Brand
Tooth Shade Resin Material
Company
Liaoning Upcera Co.,Ltd.
Model
HT-S-A3.5-D(98-22)
Published
2025-03-10
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

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942201702502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942201702502069422017025026942201702502

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
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#

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815967025856RodinPac-Dent, Inc.EBF2026-03-24
00815967025863RodinPac-Dent, Inc.EBF2026-03-24
00815967025870RodinPac-Dent, Inc.EBF2026-03-24
00815967021438OptiCompPac-Dent, Inc.EBF2026-03-23
00815967021797OptiCompPac-Dent, Inc.EBF2026-03-23
00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
00815967028185RodinPac-Dent, Inc.EBF2026-03-23
00815967028192RodinPac-Dent, Inc.EBF2026-03-23
00815967028208RodinPac-Dent, Inc.EBF2026-03-23
00815967028215RodinPac-Dent, Inc.EBF2026-03-23
00815967028222RodinPac-Dent, Inc.EBF2026-03-23
00815967028239RodinPac-Dent, Inc.EBF2026-03-23
00815967028246RodinPac-Dent, Inc.EBF2026-03-23
00815967028253RodinPac-Dent, Inc.EBF2026-03-23
00815967028260RodinPac-Dent, Inc.EBF2026-03-23
00815967028277RodinPac-Dent, Inc.EBF2026-03-23
00815967028284RodinPac-Dent, Inc.EBF2026-03-23
00815967028291RodinPac-Dent, Inc.EBF2026-03-23
00815967028307RodinPac-Dent, Inc.EBF2026-03-23
00815967028314RodinPac-Dent, Inc.EBF2026-03-23
00815967028321RodinPac-Dent, Inc.EBF2026-03-23
00815967028338RodinPac-Dent, Inc.EBF2026-03-23
00815967028345RodinPac-Dent, Inc.EBF2026-03-23
00815967028352RodinPac-Dent, Inc.EBF2026-03-23
00815967028369RodinPac-Dent, Inc.EBF2026-03-23
00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23