FDA.reportPublic FDA data

EnaCem HF

Primary DI
EMICCPCK1
Brand
EnaCem HF
Company
MICERIUM SPA
Model
CPCK
Catalog number
CPCK
Device description
ENACEM HF+BONDING COMPLETE KIT1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle8 CPCTIPN-1 AUTOMIX ENACEM needle4 CPCTIPS-1 Intraoral Syringe Needle
Published
2021-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062355000
K072978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062355000ENA CEMMicerium S.P.A.2006-12-27EMA
K072978000TENDER ORTHO BOND-ENA BOND-ENA ETCHMicerium S.P.A.2008-01-17DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICCPCK1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius10 Degrees Celsius

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
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00190746134432BracePaste Prime PlusAMERICAN ORTHODONTICS CORPORATIONDYH2026-09-29
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
08809262950823OrthoFitSpident Co., Ltd.DYH2026-07-14
08809262957983OrthoFitSpident Co., Ltd.DYH2026-07-14
08809262957990OrthoFitSpident Co., Ltd.DYH2026-07-14
00371347022292Advance Dental ProductsThe Atlanta Dental Supply CompanyDYH2026-07-08
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04