FDA.reportPublic FDA data

Renamel® Flowable Microhybrid

Primary DI
D7797011A30
Brand
Renamel® Flowable Microhybrid
Company
COSMEDENT, INC.
Model
7011A3
Catalog number
7011A3
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222435000
K980298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222435000Renamel® Microhybrid ;Renamel® Flowable MicrohybridCosmedent, Inc.2022-10-11EBF
K980298000FLOWABLE HYBRIDCosmedent, Inc.1998-03-09EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7797011A30PrimaryHIBCC0

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
113911689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7796611010PorcelEtch6611016611012016-09-22
D7796631010PorcelEtch6631016631012016-09-22
D7796631020PorcelEtch6631026631022016-09-22
D7796631030CompositeEtch6631036631032016-09-22
D7796631040PorcelEtch6631046631042016-09-22
D7796040153Prevue Refill Kit6040156040152016-09-22
D7799060000Enamelize9060009060002016-09-22
D7799061010Enamelize9061019061012016-09-22
D7799061040Porcelize9061049061042016-09-22
D7799061050Porcelize9061059061052016-09-22
D7799061021Porcelize Kit9061022020-01-21
D7796541030Complete Dual-Cure Catalyst6541036541032016-09-22
D7796541040Complete Unfilled Resin6541046541042016-09-22
D7796061A20Renamel® Microhybrid6061A26061A22016-09-22
D7796062A21Renamel® Microhybrid6062A26062A22016-09-22
D7796062B21Renamel® Microhybrid6062B26062B22016-09-22
D7796062MI1Renamel® Microhybrid6062MI6062MI2016-09-22
D779100ROD1IPC Off-Angle Long100ROD2023-09-12
D77990110114ResinKeeper9011012020-02-17
D77970110W0Renamel® Flowable Microhybrid70110W70110W2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990516ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990523ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14