FDA.reportPublic FDA data

BISICO Repo-Core DC A3 25ml

Primary DI
EBIB752201
Brand
BISICO Repo-Core DC A3 25ml
Company
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Model
75220
Catalog number
75220
Device description
Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
Published
2020-06-18
Public version status
Update
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
K984097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984097000DC-CORES & C Polymer GmbH1999-02-09EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBIB752201PrimaryHIBCC0

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 Temperature0 Degrees Celsius20 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius20 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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