FDA.reportPublic FDA data

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

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

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
06909412319455Dental ModelM 2.01.0 kg/bottle2026-05-19
06909412319929Porcelain PowdersPowderA/10g2026-05-19
06909412319936Porcelain PowdersPowderB/10g2026-05-19
06909412320024Porcelain PowdersBlending LiquidL1/20mL2026-05-19
06909412320031Porcelain PowdersBlending LiquidL2/20mL2026-05-19
06909412320048Porcelain PowdersStain/GlazeA/5g2026-05-19
06909412320055Porcelain PowdersStain/GlazeB/5g2026-05-19
06909412320246Porcelain Powders/K-001-162026-05-19
06909412327825Dental ModelM 3.01.0 kg/bottle2026-05-19
06909412327900Denture BaseDB2S/500 g/bottle2026-05-19
06909412327917Denture BaseDB2S/1.0 kg/bottle2026-05-19
06909412327924Denture BaseDBPink/500 g/bottle2026-05-19
06909412327931Denture BaseDBPink/1.0 kg/bottle2026-05-19
06909412327948Denture BaseDBPink1/500 g/bottle2026-05-19
06909412327955Denture BaseDBPink1/1.0 kg/bottle2026-05-19
06909412327962Denture BaseDBPink2/500 g/bottle2026-05-19
06909412327979Denture BaseDBPink2/1.0 kg/bottle2026-05-19
06909412327986Denture BaseDBPink3/500 g/bottle2026-05-19
06909412327993Denture BaseDBPink3/1.0 kg/bottle2026-05-19
06909412328006Denture BaseDBPink4/500 g/bottle2026-05-19

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