FDA.reportPublic FDA data

Prime-Core Chemical Cure Core Build Up

Primary DI
00817441023556
Brand
Prime-Core Chemical Cure Core Build Up
Company
PRIME DENTAL
Model
003-018
Device description
Prime Core Chemical Cure Core Build Up Kit 15g/15g WHITE
Published
2017-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022675000PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALPrime Dental Manufacturing, Inc.2002-11-07EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817441023556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817441023556008174410235568174410235560817441023556

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
027480775
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817441020005Prime-Dent Visible Light Cure Nano-Hybrid Composite001-6102016-08-10
00817441022658Prime Dent Light Cure One Step Dentin/Enamel Bonding Adhesive006-0302023-11-21
00817441023136Prime Dent Etchant Liquid008-0402023-11-21
00817441022269Prime-CrownA12019-11-06
00817441023433Prime Dent Tray Adhesive Blue017-0202017-01-04
00817441023549Scott's Select RC Cream 2-9gm Syringe199-10362016-09-26
00817441020012Prime Dent Visible Light Cure Nano Hybrid Composite Shade001-601A12019-11-06
00817441020029Prime Dent Visible Light Cure Nano Hybrid Composite 001-601A22019-11-06
00817441020326Prime Dent Visible Light Cure Hybrid Composite Shade A3001-001A32017-01-04
00817441020524Prime Dent Visible Light Cure Hybrid Composite Shade A2001-001A12017-01-04
00817441020548Prime Dent Flowable Composite Shade A3.5004-010A3.52017-01-04
00817441020722Prime Dent Flowable Composite Shade A1004-010A12017-01-04
00817441020739Prime Dent Flowable Composite Shade A2004-101A22017-01-04
00817441020999Prime Dent Visible Light Cure Micro Hybrid Composite001-4142017-01-04
00817441023532Scott's Select Temporary Cement NE Jars199-10092016-09-26
00817441023563Prime-Core DC Automix Core Build Up Material003-0612017-01-04

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Primary DI, Brand, Company table
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00810111543644QuantiumBISCO INC.EBF2026-10-12
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00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
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08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07