FDA.reportPublic FDA data

TempSpan

Primary DI
00814978022212
Brand
TempSpan
Company
Kerr Corporation
Model
N69AD
Device description
Temporary C&B Material; A3
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814978022212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814978022212008149780222128149780222120814978022212

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19
00195062145278ZenFlex CM818-36052026-02-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201747329FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747398FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747404FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747497FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747589FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747596FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747688FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747695FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747701FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747886FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747978FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201746728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747114FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747190FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
08800055726953C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02