FDA.reportPublic FDA data

Elastomeric Impression Material

Primary DI
06909412313187
Brand
Elastomeric Impression Material
Company
SHANDONG HUGE DENTAL MATERIAL CORPORATION
Model
Type 1 (Heavy Body Dispenser-Mix Normal Set)
Catalog number
50ml/bio-cartridge, 2 bio-cartridges/box/Mixer(Whi
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133071000ELASTIC IMPRESSION MATERIALRizhao Huge Dental Industry Co., Ltd.2014-05-28ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909412313187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909412313187069094123131876909412313187

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Regulatory Flags#

DUNS number
528184691
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
false
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
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
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
06970402679958Elastomeric Impression MaterialType 0 (Putty Hand-Mix)25g Catalyst*402026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412304789Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313163Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06909412313170Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679941Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
06970402679958Elastomeric Impression MaterialSHANDONG HUGE DENTAL MATERIAL CORPORATIONELW2026-10-26
00197998040627Solventum™ Paradigm™Solventum US LLCELW2026-10-24
00197998040733Solventum™ Paradigm™Solventum US LLCELW2026-10-24
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20