FDA.reportPublic FDA data

Core Paste®

Primary DI
D8130306571100
Brand
Core Paste®
Company
DEN-MAT HOLDINGS, LLC
Model
030657110
Catalog number
030657110
Device description
C PST ENMwFL DC XP SY INTRO KT
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8130306571100PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Bring the product to room temperature prior to use.
Special Storage Condition, Specify00Do not expose the product to direct sunlight
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Store under refrigeration
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13
00359883000608PowerMix™ Automatic Impression Material Dispenser0311210311212025-03-12
00359883000615PowerMix™ Dynamic Mixing Tips0335390335392025-03-12
00359883000882Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange2090072090072025-03-12
00359883000899Dual-Force™ Sectional Matrix System Molar Rings Green2090082090082025-03-12
00359883000929Dual-Force™ Sectional Matrix System Promo Ring Molar Green2090162090162025-03-12
00359883001353True™ Dental Dam Latex Free 5x58382008382002025-03-12
00359883001360True™ Dental Dam Latex Free 6x68382018382012025-03-12
00359883001377True™ Dental Dam Latex Free 5x5 Heavy Gauge8382028382022025-03-12
00359883001384True™ Dental Dam Latex 6x68382368382362025-03-12
00359883001391True™ Dental Dam Latex 6x6 Heavy Gauge8382378382372025-03-12
00359883001407True™ Dental Dam Latex 5x58382528382522025-03-12
00359883001414True™ Dental Dam Latex 5x5 Heavy Gauge8382538382532025-03-12
00359883001421ResinBlend LV Composite Blending Resin Unit Dose9701519701512025-03-12
00359883001438True™ Dental Dam Latex Free 6x6 Heavy Sample9783829783822025-03-12

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Primary DI, Brand, Company table
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00815967027447RodinPac-Dent, Inc.EBF2026-03-23
00815967028161RodinPac-Dent, Inc.EBF2026-03-23
00815967028178RodinPac-Dent, Inc.EBF2026-03-23
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00815967028376RodinPac-Dent, Inc.EBF2026-03-23
00815967028383RodinPac-Dent, Inc.EBF2026-03-23
00815967028390RodinPac-Dent, Inc.EBF2026-03-23