FDA.reportPublic FDA data

JMU

Primary DI
00840456200100
Brand
JMU
Company
JMU DENTAL, INC
Model
31501001
Device description
JMU Dental Impression Materials, Putty - Normal Set, 400g Base+400g Catalyst/set with 2 Measuring Spoons
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840456200100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456200100008404562001008404562001000840456200100

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081258380
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
00840456202814JMU240070062026-07-24
00840456214701JMU242010022026-07-24
00840456214718JMU242010012026-07-24
00840456224465JMU233010142026-07-24
00840456202807JMU240070052026-07-23
00840456214664JMU240070042026-07-23
00840456214671JMU240070032026-07-23
00840456214688JMU240070022026-07-23
00840456214695JMU240070012026-07-23
00840456215753JMU369430012026-07-22
00840456218600JMU321130062026-07-22
00840456218617JMU321130072026-07-22
00840456224366JMU133010092026-07-22
00840456224373JMU170040162026-07-22
00840456224380JMU170040172026-07-22
00840456224397JMU170010862026-07-22
00840456224403JMU170010872026-07-22
00840456224410JMU170010882026-07-22
00840456224441JMU231010032026-07-22
00840456200940JMU101070042026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28