FDA.report

Mojo

Primary DI
00814978020195
Brand
Mojo
Company
Kerr Corporation
Model
N06AB
Device description
Veneer Cement; Syringe; Try-In-Gel; Dark
Published
2016-08-01
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
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814978020195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814978020195008149780201958149780201950814978020195

GMDN Terms

TermDefinition
Dental cement trialA non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight1.6Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+18005377123customercare@kavokerrgroup.com

Regulatory Flags

DUNS number
199354556
Device count
1
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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00195062145285ZenFlex CM818-36062026-02-19
00195062145292ZenFlex CM818-36072026-02-19
00195062145308ZenFlex CM818-36082026-02-19
00195062145315ZenFlex CM818-36092026-02-19
00195062145322ZenFlex CM818-36102026-02-19
00195062145339ZenFlex CM818-36112026-02-19
00195062145346ZenFlex CM818-36122026-02-19
00195062145353ZenFlex CM818-36132026-02-19
00195062145360ZenFlex CM818-36142026-02-19
00195062145377ZenFlex CM818-36152026-02-19
00195062145384ZenFlex CM818-36162026-02-19
00195062145391ZenFlex CM818-36172026-02-19
00195062145407ZenFlex CM818-36182026-02-19
00195062145759ZenFlex CM818-35912026-02-19
00195062145766ZenFlex CM818-35922026-02-19
00195062145773ZenFlex CM818-36912026-02-19

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00815967029656RodinPac-Dent, Inc.EMA2026-03-23
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00815967029687RodinPac-Dent, Inc.EMA2026-03-23
00815967029694RodinPac-Dent, Inc.EMA2026-03-23
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00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
07290115050400High-Q-Bond SEB.J.M. LABORATORIES LTDEMA2026-03-20
00817169021438UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00817169021445UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
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00840479201603GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
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