FDA.reportPublic FDA data

Take 1 Advanced

Primary DI
10841396118538
Brand
Take 1 Advanced
Company
KERR CORPORATION
Model
34697
Device description
Volume - Impression Material - Tray - Super Fast Set - 2 Hard Cartridges (380 ml each)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091613000TAKE 1Kerr Corp.2009-10-07ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841396118538PrimaryGS10
00841396118531Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084139611853810841396118538
00841396118531008413961185318413961185310841396118531

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume760Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags#

DUNS number
847905890
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841396116285NX333642336422016-08-01
10814978021267Build-It FRN32FA2016-08-01
10814978021281Build-It FRN32FB2016-08-01
10814978021298Build-It FRN32FC2016-08-01
10814978021304Build-It FRN32FD2016-08-01
10814978021311Build-It FRN32FE2016-08-01
10814978023230Build-It FRN322016-08-01
00814978021185Build-It FRN32AA2016-08-01
00814978021192Build-It FRN32AB2016-08-01
00814978021208Build-It FRN32AC2016-08-01
00814978021215Build-It FRN32AD2016-08-01
00814978021222Build-It FRN32AE2016-08-01
00814978021321Build-It FRN32FS2016-08-01
00814978021338Build-It FRN32FSA2016-08-01
00814978021345Build-It FRN32FSB2016-08-01
00814978021352Build-It FRN32FSC2016-08-01
00814978021369Build-It FRN32FSD2016-08-01
00814978021437Cement-It Universal C&BN33A2016-08-01
00814978021444Cement-It Universal C&BN33AB2016-08-01
00814978021451Cement-It Universal C&BN33AC2016-08-01

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
06909412313187Elastomeric 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