FDA.reportPublic FDA data

Flex Tab

Primary DI
10841396117319
Brand
Flex Tab
Company
KERR CORPORATION
Model
004-008
Device description
Flexible Clearance Tabs (Blue)
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFHPAPER, ARTICULATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841396117319PrimaryGS10
00841396117312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084139611731910841396117319
00841396117312008413961173128413961173120841396117312

GMDN Terms#

Term, Definition table
TermDefinition
Interproximal/occlusal dental gauge, single-useA device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE AT AMBIENT TEMPERATURE

Contacts#

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

Regulatory Flags#

DUNS number
847905890
Device count
30
Premarket exempt
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040600001ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600011ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600071ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
08906110440175Maarc dental - Articulating PaperSHIVA PRODUCTSEFH2024-10-02
00889813062081Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062098Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062104Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062128Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062135Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062142Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062159Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062166Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062088Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062095Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062101Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062125Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062132Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062149Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062156Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062163Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062173Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
D956OCCLUFL0DSI Occlufoil 6mmD.S.I DENTAL SOLUTIONS LTDEFH2024-07-01
10732224001712Articulating PaperCROSSTEX INTERNATIONAL, INC.EFH2024-04-12
D040600081ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600130ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040602061ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600021ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D040600031ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D248720010"Madam Butterfly Silk 3/4"" Blue"HAGER WORLDWIDE, INC.EFH2023-05-15
D248720020"Madam Butterfly Silk 3/4"" Grn"HAGER WORLDWIDE, INC.EFH2023-05-15