FDA.reportPublic FDA data

FRESH Bold Impression Material

Primary DI
00815619020574
Brand
FRESH Bold Impression Material
Company
EXACTA DENTAL PRODUCTS INC
Model
Clear Bite Cartridge
Catalog number
1-7494
Device description
FRESH Bold Impression Material Clear Bite Cartridge
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
00815619020574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815619020574008156190205748156190205740815619020574

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
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
00815619020871FRESH Bold Impression MaterialHeavy Body Mega Pack7483M2016-09-23
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
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
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08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08