FDA.reportPublic FDA data

Vivid TruEtch 40% Unisyringe

Primary DI
D724H6503041
Brand
Vivid TruEtch 40% Unisyringe
Company
PEARSON DENTAL SUPPLIES, INC.
Model
H65-0304
Device description
12gm
Published
2018-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D724H6503041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
082874108
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D724H6503001Vivid TruEtch 40% H65-03002018-05-09
D724H6503021Vivid TruEtch 40% H65-03022018-05-09
D724H6503061Vivid TruEtch 40% Jumbo syringeH65-03062018-05-09
D724H6503081Vivid TruEtch 40% Jumbo syringeH65-03082018-05-09
D724H6503101Vivid TruEtch 10% Kit H65-03102018-05-09
D724Z0603121Vivid Etch 40%z0603122016-06-29
D724Z0603141Vivid Etch 40%Z0603142016-06-29
D724Z0603160Vivid Etch 40%Z0603162016-06-29
D724Z0603180Vivid Etch 40% refillZ0603182016-06-29
D724Z0603200VividEtch 40% Jumbo 60gm RefillZ0603202016-07-07
D724Z0603241Vivid Etch 10%z0603242016-06-29
D724D4407260Vivid TempFill LCD4407462016-06-28
D724S2702701Vivid Root MTA S2702702016-06-30
D724J0800061N'Sure Indicator TapeJ0800062016-07-26
D724J0800081N'Sure Indicator TapeJ0800082016-07-26
D724J0800101N'Sure Indicator TapeJ0800102016-07-26
D724D0104501Vivid Surebond VIID0104502016-06-21
D724D0104521Vivid Surebond VII RefillD0104522016-06-21
D724S2702601Vivid Ceramic PrimeS2702602016-06-30
D724B0105080Vivid Electrode Tip #11B8805082016-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24
D0019064020LucitoneDentsply International Inc.KLE2023-11-14
D0019064030LucitoneDentsply International Inc.KLE2023-11-14
D0019064040LucitoneDentsply International Inc.KLE2023-11-14
D0019064050LucitoneDentsply International Inc.KLE2023-11-14
07615208293128Adhese 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208295375Monobond Etch & PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296136Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208296143Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297362ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208297379ExciTE FIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-04-06
07615208302684SyntacIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2023-03-29
10371347008729Advance Dental ProductsThe Atlanta Dental Supply CompanyKLE2022-12-29