Glass Ionomer Cement (Luting)

Primary DI
06970402670276
Brand
Glass Ionomer Cement (Luting)
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Luting I, Luting II
Catalog number
Powder: 10g; Liquid: 10g
Published
2017-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161851000Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation2016-10-31EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970402670276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970402670276069704026702766970402670276

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528184691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909412304789Elastomeric Impression MaterialType 0 (Putty Hand-Mix Fast Set)400g base+400g catalyst/box2026-10-26
06909412313088Light Curing Tray/Mint/Blue, 2.3mm, 2 pieces*12026-10-26
06909412313095Light Curing Tray/Mint/Blue, 2.3mm, 50 pieces*12026-10-26
06909412313163Elastomeric Impression MaterialType 3 (Light Body Dispenser-Mix Fast Set)50ml/bio-cartridge, 2 bio-cartridges/box2026-10-26
06909412313170Elastomeric Impression MaterialType 1 (Heavy Body Dispenser-Mix Fast Set)50ml/bio-cartridge, 2 bio-cartridges/box/Mixer(Whi2026-10-26
06909412313187Elastomeric Impression MaterialType 1 (Heavy Body Dispenser-Mix Normal Set)50ml/bio-cartridge, 2 bio-cartridges/box/Mixer(Whi2026-10-26
06909412319448Firing Paste/10mL2026-10-26
06909412320192Light Curing Tray/Mint/Pink, 1.6mm, 50 pieces*12026-10-26
06909412320222Light Curing Tray/Mint/Blue, 1.6mm, 50 pieces*12026-10-26
06909412320413Light Curing Tray/Mint/Pink, 1.6mm, 2 pieces*12026-10-26
06909412320420Light Curing Tray/Mint/Pink, 2.0mm, 2 pieces*12026-10-26
06909412320437Light Curing Tray/Mint/Blue, 2.0mm, 2 pieces*12026-10-26
06909412358546Zirconia BlockMM-4D/2026-10-26
06970402679033Light Curing Tray/Mint/Pink, 2.0mm, 50 pieces*12026-10-26
06970402679040Light Curing Tray/Mint/Blue, 2.0mm, 50 pieces*12026-10-26
06970402679057Light Curing Tray/Mint/Pink, 1.4mm, 50 pieces*12026-10-26
06970402679064Light Curing Tray/Mint/Blue, 1.4mm, 50 pieces*12026-10-26
06970402679309Light Curing Tray/Mint/Pink, 2.3mm, 2 pieces*12026-10-26
06970402679927Light Curing Tray/Mint/Pink, 2.3mm, 50 pieces*12026-10-26
06970402679941Elastomeric Impression MaterialType 0 (Putty Hand-Mix)25g Base*402026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998118227Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118234Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118241Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118258Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118265Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118623Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118630Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00195062160110NX3Kerr CorporationEMA2026-10-29
00195062159787BreezeKerr CorporationEMA2026-10-27
00195062159794Breeze RMGIKerr CorporationEMA2026-10-27
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20