Temp-Bond NE

Primary DI
10841396112888
Brand
Temp-Bond NE
Company
KERR CORPORATION
Model
31973
Device description
Temporary Crown and Bridge Cement Zinc Oxide Unidose
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
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003658000TEMP-BOND NE 2Sybron Dental Specialties, Inc.2001-01-04EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841396112888PrimaryGS10
00841396112881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084139611288810841396112888
00841396112881008413961128818413961128810841396112881

GMDN Terms#

Term, Definition table
TermDefinition
Ethoxy benzoic acid dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between ethoxy benzoic acid (EBA) and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight120Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
847905890
Device count
50
Lot or batch
true
Expiration date on label
true

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00195062145629ZenFlex CM818-36062026-02-19
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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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