FDA.reportPublic FDA data

Guardian Seal

Primary DI
00841396116865
Brand
Guardian Seal
Company
Kerr Corporation
Model
31539
Catalog number
31539
Device description
Filled Pit and Fissure Sealant; Sample
Published
2016-08-01
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
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841396116865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841396116865008413961168658413961168650841396116865

GMDN Terms#

Term, Definition table
TermDefinition
Dental pit/fissure sealantA resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Gram

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
199354556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145582ZenFlex CM818-36022026-02-19
00195062145599ZenFlex CM818-36032026-02-19
00195062145605ZenFlex CM818-36042026-02-19
00195062145612ZenFlex CM818-36052026-02-19
00195062145629ZenFlex CM818-36062026-02-19
00195062145636ZenFlex CM818-36072026-02-19
00195062145643ZenFlex CM818-36082026-02-19
00195062145650ZenFlex CM818-36092026-02-19
00195062145667ZenFlex CM818-36102026-02-19
00195062145674ZenFlex CM818-36112026-02-19
00195062145681ZenFlex CM818-36122026-02-19
00195062145698ZenFlex CM818-36132026-02-19
00195062145704ZenFlex CM818-36142026-02-19
00195062145711ZenFlex CM818-36152026-02-19
00195062145728ZenFlex CM818-36162026-02-19
00195062145735ZenFlex CM818-36172026-02-19
00195062145742ZenFlex CM818-36182026-02-19
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19

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