FDA.report

Take 1 Advanced

Primary DI
10841396102452
Brand
Take 1 Advanced
Company
KERR CORPORATION
Model
34805
Device description
Impression Material - Product Sample - Light Body - Tray - Fast Set - 2 Cartridges (50 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841396102452PrimaryGS10
00841396102455Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084139610245210841396102452
00841396102455008413961024558413961024550841396102455

GMDN Terms

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

TypeValueUnit
Total Volume100Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature

Sterilization Methods

Method

Contacts

PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags

DUNS number
847905890
Device count
2
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

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E241AA9050Cavex CleverCast - Slow SetCavex Holland B.V.ELW2026-03-05
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E241AA6051Cavex Cream Fast Cavex Holland B.V.ELW2026-03-04
07630243601684AdhesiveDent4You AGELW2026-02-10
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00850079280311cAVEXHexa DentalELW2026-01-21
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