FDA.reportPublic FDA data

Intra-Oral-Tip yellow 100

Primary DI
EBIB019651
Brand
Intra-Oral-Tip yellow 100
Company
bisico Bielefelder Dentalsilicone GmbH & Co. KG
Model
01965
Catalog number
01965
Device description
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
Published
2020-06-24
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
EBIB019651PrimaryHIBCC0

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
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
EBIB019701Mixing Tips Pink 5001970019702020-06-23

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