FDA.reportPublic FDA data

ENA CEM HV

Primary DI
EMICCPCBD30
Brand
ENA CEM HV
Company
MICERIUM SPA
Model
CPCBD3
Catalog number
CPCBD3
Device description
Ena Cem HV BD3 (A3) 2g Light curing composite
Published
2025-04-03
Public version status
New
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
K062906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062906000ENA HFO COMPOSITE SYSTEMMicerium S.P.A.2006-11-17EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICCPCBD30PrimaryHIBCC0

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
436661136
Device count
1
Kit
true
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
EMICCOSZ251Ena Etch ®COSZ25COSZ252025-12-18
EMICESA01Ena ShinyESA0ESA02025-11-07
EMICESB01Ena ShinyESB0ESB02025-11-07
EMICCOS1010Ena Etch ®COS101COS1012018-11-16
EMICCOS101B0Ena Etch ®COS101BCOS101B2018-11-16
EMICCOSM1011Ena Etch ®COSM101COSM1012018-11-21
EMICCOSM101A1Ena Etch ®COSM101ACOSM101A2018-11-21
EMICCOSM101B1Ena Etch ®COSM101BCOSM101B2018-11-16
EMICCOSZ1001Ena Seal ®COSZ100COSZ1002018-11-21
EMICESG71Ena ShinyESG7ESG72021-02-12
EMICESG11Ena ShinyES+GES+G2024-08-06
EMICESYG0Ena ShinyES-Y+GES-Y+G2023-06-09
EMICESKIT01Ena ShinyESKITESKIT2023-06-08
EMICESA0Ena ShinyESAESA2021-02-12
EMICESA1Ena ShinyESAESA2021-02-12
EMICESB0Ena ShinyESBESB2021-02-12
EMICESB1Ena ShinyESBESB2021-02-12
EMICESC0Ena ShinyESCESC2021-02-12
EMICESC1Ena ShinyESCESC2021-02-12
EMICESC40Ena ShinyESC4ESC42021-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07
07630243601301ParaCoreDent4You AGEBF2026-07-07
07630243634743ParaCoreDent4You AGEBF2026-07-07
07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702947SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702992SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703005SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02