FDA.report

FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement

Primary DI
D0026126001
Brand
FluoroCore® 2+ Dual Cure Core Build-up Material + Fast Endodontic Post Cement
Company
DENTSPLY INTERNATIONAL INC.
Model
612600
Catalog number
612600
Device description
FluoroCore® 2+ Introductory Kit
Published
2022-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KLEAGENT, TOOTH BONDING, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026126001PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Syringes should be stored with the original cap only. Keep out of direct sunlight and protect from moisture. Allow material to reach room temperature prior to use. Do not freeze.
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21
D0013010321Ceramco® 3Powder Opaque Modifier Sienna3010322016-09-21
D0013010361Ceramco® 3Powder Opaque Modifier Pink3010362016-09-21
D0013010371Ceramco® 3Powder Opaque Modifier Ochre3010372016-09-21
D0013010481Ceramco® 3Paste Opaque A3.53010482016-09-21
D0013010591Ceramco® 3Paste Opaque C23010592016-09-21
D0013010701Ceramco® 3Paste Opaque Modifiers White3010702016-09-21
D0013011031Ceramco® 3Opaceous Dentin i13011032016-09-21
D0013011071Ceramco® 3Opaceous Dentin A3.53011072016-09-21
D0013011101Ceramco® 3Opaceous Dentin i63011102016-09-21
D0013011181Ceramco® 3Opaceous Dentin C23011182016-09-21
D0013011221Ceramco® 3Opaceous Dentin D33011222016-09-21
D0013011501Ceramco® 3Dentin C43011502016-09-21
D0013011611Ceramco® 3Dentin Modifier A3.53011612016-09-21
D0013011671Ceramco® 3Dentin Modifier Blue3011672016-09-21
D0013012001Ceramco® 3Natural Enamel White3012002016-09-21
D0013012011Ceramco® 3Natural Enamel Extra Light3012012016-09-21
D0013013221Ceramco® 3Overglaze3013222016-09-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967022503PacBondPac-Dent, Inc.KLE2026-03-24
00815967023005PacBondPac-Dent, Inc.KLE2026-03-24
00815967027454RodinPac-Dent, Inc.KLE2026-03-24
00815967027461RodinPac-Dent, Inc.KLE2026-03-24
00815967027478RodinPac-Dent, Inc.KLE2026-03-24
00815967027485RodinPac-Dent, Inc.KLE2026-03-24
00815967022404PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022411PacEtchPac-Dent, Inc.KLE2026-03-23
00815967022589PacEtchPac-Dent, Inc.KLE2026-03-23
00815967029984RodinPac-Dent, Inc.KLE2026-03-23
DVIV687778WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
DVIV687779WW0Adhese Universal DCIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-03-17
07290115050196Prima Quick PrimeB.J.M. LABORATORIES LTDKLE2026-03-13
07290115051889Smile Stream STEP-1 PumEtchB.J.M. LABORATORIES LTDKLE2026-03-13
00840479203409SELF ETCHING PRIMER REFILL CARTRIDGERELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840479203546ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-03-12
00840481135286MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840481135293MICROPRIMEZest Anchors, LLCKLE2026-03-10
00840479200767ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200859BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200897ASSURE UNIVERSAL BONDING RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-23
00840479200781ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200798ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200804ASSURE PLUS ALL SURFACE RESINRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203591ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479203607ULTRA SELF ETCHING PRIMERRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-20
00840479200071BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00840479200088BLUE ETCH GEL WITH BACRELIANCE ORTHODONTIC PRODUCTS INCKLE2026-02-18
00190746071003Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-01-28
00850079280120HexaHexa DentalKLE2026-01-21