FDA.reportPublic FDA data

Micro Esthetic Gingiva G-D

Primary DI
EBIB750781
Brand
Micro Esthetic Gingiva G-D
Company
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Model
75078
Catalog number
75078
Device description
Light curing, flowable and gingival colored composit for fillings of Black’s class V. Reproduction of the natural gingiva. Is used in dentistry.
Published
2020-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K151399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151399000Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowSchutz Dental GmbH2016-10-24EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBIB750781PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+495218016800info@bisico.de

Regulatory Flags#

DUNS number
316133664
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBIB752501E-Bond DC75250752502020-06-10
EBIB752651E-Bond LC75265752652020-06-10
EBIB001101BISICO Plast00110001102023-06-28
EBIB012001BISICO S3 Heavy 2x170ml01200012002023-06-28
EBIB019101BISICO Dispenser 5001910019102023-06-28
EBIB019201BISICO Dispenser 7501920019202023-06-28
EBIB019401BISICO Dispenser 2501940019402023-06-28
EBIB020201BISICO Dispenser 4:102020020202023-06-28
EBIB712301BISICO S3 i Heavy 4x75ml71230712302023-06-28
EBIB723211BISICO S4 suhy - impressa sure light72321723212023-06-28
EBIB017901Intra-Oral-Tip white 5001790017902020-06-24
EBIB018001Intra-Oral-Tip Core 5001800018002020-06-24
EBIB019601Intra-Oral-Tip yellow 5001960019602020-06-24
EBIB019651Intra-Oral-Tip yellow 10001965019652020-06-24
EBIB021001BRT bite-registration-Tip flat 5002100021002020-06-24
EBIB021051BRT bite-registration-Tip flat 10002105021052020-06-24
EBIB017801Mixing Tips Yellow 5:1 5001780017802020-06-23
EBIB019501Mixing Tips Yellow 5001950019502020-06-23
EBIB019551Mixing Tips Yellow 10001955019552020-06-23
EBIB019571Mixing Tips Yellow long version 5001957019572020-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29