FDA.reportPublic FDA data

BioCoat

Primary DI
00348783000863
Brand
BioCoat
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
3001531
Device description
BioCoat Pit/Fissure Value Pk (4)
Published
2023-10-13
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161580000Premier SealantPremier Dental Company Products2016-10-18EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783000863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783000863003487830008633487830008630348783000863

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
014789663
Device count
1
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
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

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