FDA.reportPublic FDA data

Mixing Tips Pink 50

Primary DI
EBIB019701
Brand
Mixing Tips Pink 50
Company
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Model
01970
Catalog number
01970
Device description
Mixing tips to attach to a cartridge. The cartridge is filled with 2-component impression silicone, dental cement or similar.The mixing tip has a spiral inside with which the 2 components can be mixed and comes out mixed on the front. Used in dentistry.
Published
2020-06-23
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
EIDSyringe, Restorative And Impression Material

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBIB019701PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
316133664
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing 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
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15