FDA.reportPublic FDA data

FormCore DC

Primary DI
18522530060211
Brand
FormCore DC
Company
J. MORITA U.S.A., INC
Model
28700100
Device description
Dental Composite Resin for Core Build-up
Published
2016-09-22
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
true

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
K061664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061664000FORMCORE DC, MODEL 28-700100J. Morita USA, Inc.2006-09-08EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18522530060211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1852253006021118522530060211

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
021866033
Device count
1
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08522530060382Free Access II Cheek Retractor Large21303100L2023-06-07
08522530060399Free Access II Cheek Retractor Small21303100S2023-06-07
10852253006240Power Temp Cartridge Kit27410002023-06-07
10852253006257Power Temp Mini Syringe Kit288001002023-06-07
00852253006403Rotary Master Plus1653500002025-05-22
10852253006189Max Bond LC Kit282001002016-09-22
10852253006196Max Bond LC Agent A282002002016-09-22
10852253006202Max Bond LC Agent B282003002016-09-22
00852253006380Free Access II Cheek Retractor Large21303100L2023-07-13
00852253006397Free Access II Cheek Retractor Small21303100S2023-07-13
10852253006127Perfectim Tissue Mimic 213011002016-09-22
10852253006165Silk Line Varnish BaseSilk Line Varnish Base2016-09-22
10852253006172Silk Line Varnish CatalystSilk Line Varnish Catalyst2016-09-22
10852253006233CB Temp A3286002002016-09-22
00852253006274CF Carbon Fiber Post Kit231005502021-10-28
00852253006328GF Glass Fiber Post Kit231005802021-10-28
10852253006226CB Temp A2286001002016-09-22
00852253006090Perfectim Putty Type Kit213000502016-09-22
10852253006011Perfectim 30 Second Blue Velvet213005002016-09-22
10852253006028Perfectim 90 Second Blue Velvet213005502016-09-22

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Primary DI, Brand, Company table
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08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
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08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
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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
08806383541152DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541169DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541176DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541183DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541190DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541206DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541213DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541220DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541237DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541244DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541251DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541268DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541299DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541305DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541312DIAFILDiaDent Group InternationalEBF2026-10-07