FDA.reportPublic FDA data

ParaBond

Primary DI
J00674930
Brand
ParaBond
Company
Coltène/Whaledent AG
Model
7493
Catalog number
7493
Published
2016-08-15
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053040000PARACEM UNIVERSAL DCColtene/Whaledent AG2005-11-09EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00674930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature4 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41717575300info.ch@coltene.com

Regulatory Flags#

DUNS number
480017482
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181476947BRILLIANT EverGlowUniv. Comp B-EA1 2025-07-08
07640181476954BRILLIANT EverGlowUniv. Comp B-EA22025-07-08
07640181476961BRILLIANT EverGlowUniv. Comp B-EA32025-07-08
07640181476985BRILLIANT EverGlowUniv. Comp B-EB12025-07-08
J00672800Etchant Gel728072802016-08-15
J00673730Etchant Gel737373732016-08-15
J00673740Etchant Gel737473742016-08-15
J00656300SwissTEC Etchant563056302016-08-15
J0065630L0SwissTEC Etchant5630 L5630 L2016-08-15
J00656310SwissTEC Etchant563156312016-08-15
J00644450PSI444544452016-08-15
J00644400PSI444044402016-08-15
07640181476879BRILLIANT Bulk Fill Flow600368242025-04-29
07640181476886BRILLIANT Bulk Fill Flow600332802025-04-29
J0006600332800BRILLIANT Bulk Fill Flow600332802024-09-22
J0006600368240BRILLIANT Bulk Fill Flow600368242024-09-22
J006600117570One Coat Bond60011757600117572016-08-15
J006600195380ONE COAT 7 UNIVERSAL60019538600195382016-08-15
J006600195390ONE COAT 7 UNIVERSAL60019539600195392016-08-15
J006600195400ONE COAT 7 UNIVERSAL60019540600195402016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29