FDA.reportPublic FDA data

Helioseal/Clear/F/F Plus

Primary DI
07615208294200
Brand
Helioseal/Clear/F/F Plus
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
686770AN
Catalog number
686770AN
Device description
Helioseal F Plus Refill 5x1.25g
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DVIV686770AN1PreviousHIBCC0
07615208294200PrimaryGS10
07615208472653Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208294200076152082942007615208294200
07615208472653076152084726537615208472653

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
448015938
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07615208570830Adhese 2 100768338WW768338WW2026-07-22
07615208474398Clinical Auxiliary (no MD)7608167608162026-07-14
07615208592634Ivotion Dent7711817711812026-07-09
07615208592689Ivotion Dent7711827711822026-07-09
07615208592696Ivotion Dent7711857711852026-07-09
07615208592702Ivotion Dent7711867711862026-07-09
07615208592719Ivotion Dent7711877711872026-07-09
07615208585728Ivotion Base7712057712052026-07-08
07615208585735Ivotion7712077712072026-07-08
07615208585742Ivotion7712087712082026-07-08
07615208585759Ivotion7712097712092026-07-08
07615208585766Ivotion7712107712102026-07-08
07615208585773Ivotion7712117712112026-07-08
07615208585780Ivotion7712127712122026-07-08
07615208585797Ivotion7712137712132026-07-08
07615208585803Ivotion7712147712142026-07-08
07615208585810Ivotion7712157712152026-07-08
07615208585827Ivotion7712167712162026-07-08
07615208585834Ivotion7712177712172026-07-08
07615208585841Ivotion7712187712182026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
306058610660213M™ Clinpro™3M COMPANYEBC2026-04-17
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07899633835232Vittra APS Unique FlowDentscare LtdaEBC2024-11-26
08806387860044Jet Flow Bulk UniversalMeta Biomed Co., Ltd.EBC2024-11-16
08806387860051Jet Flow Bulk A1Meta Biomed Co., Ltd.EBC2024-11-16
08806387860068Jet Flow Bulk A2Meta Biomed Co., Ltd.EBC2024-11-16
08806387860075Jet Flow Bulk A3Meta Biomed Co., Ltd.EBC2024-11-16
08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
D77819950611Scott's Select ColorFil Flow Single-Shade PrismaticSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
D77819950631Scott's Select ColorFil Flow BlockerSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
07615208294187Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294194Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294217Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208301335Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2023-04-06
H6686050011iSmileHarry J Bosworth CompanyEBC2023-02-20
306058610689263M™ Clinpro™3M COMPANYEBC2022-12-08
00810111542418OpaquerBISCO INC.EBC2022-10-11
00810111540629Choice 2BISCO INC.EBC2022-10-11
00810111540612Choice 2BISCO INC.EBC2022-10-10
00810111540872Duo-Link UniversalBISCO INC.EBC2022-10-10
00810111542302eCementBISCO INC.EBC2022-10-10
00810111542319eCementBISCO INC.EBC2022-10-10
00810111540117Porcelain PrimerBISCO INC.EBC2022-09-30
00810111540605Choice 2BISCO INC.EBC2022-08-02
D79645420MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D7964542CS1MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D757C3900KEU1Choice 2BISCO INC.EBC2021-06-25
D757C52410KEU1eCementBISCO INC.EBC2021-06-25
D911557418C0ORTHOSOURCEORTHOSOURCEEBC2019-11-13
00815619021526EXACTA Flow-lcEXACTA DENTAL PRODUCTS INCEBC2019-02-01