FDA.reportPublic FDA data

FRESH Bold Impression Material

Primary DI
00815619020871
Brand
FRESH Bold Impression Material
Company
EXACTA DENTAL PRODUCTS INC
Model
Heavy Body Mega Pack
Catalog number
7483M
Device description
FRESH Bold Impression Material Heavy Body Mega Pack
Published
2016-09-23
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053427000FRESH, DENTAL IMPRESSION MATERIALExacta Dental Products, Inc.2006-01-13ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815619020871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815619020871008156190208718156190208710815619020871

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
016325552
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815619021809EXACTA Temp XtraShade A1NA1-FS2016-08-30
00815619021830EXACTA Temp XtraShade A3.5NA3.5-FS2016-08-30
00815619020420FRESH Bold Impression MaterialCartridge of Bite Registration1-70672016-09-16
00815619020451EXACTA Cement Xtra1-74331-74332016-09-23
00815619020468EXACTA Cement Xtra1-74501-74502016-09-23
00815619020536FRESH Bold Impression MaterialMonophase Cartridge1-74862016-09-23
00815619020550FRESH Bold Impression MaterialMedium Body Cartridge1-74922016-09-23
00815619020567FRESH Bold Impression MaterialHeavy Body Cartridge1-74932016-09-23
00815619020574FRESH Bold Impression MaterialClear Bite Cartridge1-74942016-09-23
00815619020581FRESH Bold Impression MaterialLiquid Putty Cartridge1-74952016-09-23
00815619020598FRESH Bold Impression MaterialMonophase Fast Set Cartridge1-74962016-09-23
00815619020604FRESH Bold Impression MaterialLight Body Fast Set Cartridge1-74972016-09-23
00815619020628FRESH Bold Impression MaterialBlu Max Bite Registration Cartridge1-7701-FS2016-09-23
00815619020888FRESH Bold Impression MaterialPutty74852016-09-23
00815619021120FRESH Bold Impression MaterialBite Registration70672016-09-16
00815619021137FRESH Bold Impression MaterialBite Registration Bulk7067BK2016-09-16
00815619021168EXACTA Cement Xtra743374332016-09-16
00815619021175EXACTA Cement Xtra745074502016-09-16
00815619021267FRESH Bold Impression MaterialMonophase74862016-09-16
00815619021274FRESH Bold Impression MaterialMonophase Bulk7486BK2016-09-16

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