FDA.reportPublic FDA data

PREVENT SEAL

Primary DI
03760260221177
Brand
PREVENT SEAL
Company
ITENA CLINICAL
Model
ECHPVSEAL
Catalog number
ECHPVSEAL
Published
2017-10-31
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122521000PREVENT SEALItena Clinical2013-06-11EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760260221177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760260221177037602602211773760260221177

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
278261221
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760260221009TOTALCEMA2TTLCEM-A22016-10-15
03760260221016TOTALCEMTranslucentTTLCEM-TR2016-10-15
03760260221023DENTOTEMPautomix syringe IntroKitDTCA1-52016-10-15
03760260221030PROVITEMPAutomix syringePTEMP1-102016-10-15
03760260221047PREVENT SEALPVSEAL-1.2PVSEAL-1.22016-10-15
03760260221054DENTOCEMDCA-2.5DCA-2.52016-10-15
03760260221061TOTAL C-RAMTRANSLUCENTTTCRAM-TR2017-06-11
03760260221078TOTAL C-RAMOPAQUETTCRAM-OD2017-06-11
03760260221085OBTURYSHandmixOBHM1-52017-11-02
03760260221092OBTURYSAutomixOBAX1-52017-10-31
03760260221160TOTALCEMA2ECHTLCEM2017-10-31
03760260221184DENTOTEMPautomixECHDTP2017-10-31
03760260221207TOTAL C-RAMTRANSLUCENTECHTCRAM2017-10-31
03760260221214OBTURYSAutomixECHOBYS2017-10-31
03760260221221PROVITEMPAutomix syringeECHPVTEMP2017-10-31
03760260222006DENTOCORE AutomixDCSAK12016-10-15
03760260222013DENTOCORE BODYAutomixDABODY1-102016-10-15
03760260222020DENTOCORE BODYCartridge A3DCBODY-502016-10-15
03760260222037DENTOCORE Cartridge white shadeDCB-502016-10-15
03760260222044DENTOCORE Cartridge A3 shadeDCA3-502016-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
306058610660213M™ Clinpro™3M COMPANYEBC2026-04-17
306058610660833M™ Clinpro™3M COMPANYEBC2026-04-17
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
07615208294200Helioseal/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
00815619021526EXACTA Flow-lcEXACTA DENTAL PRODUCTS INCEBC2019-02-01