FDA.reportPublic FDA data

Dynamic-static Mixing Tips

Primary DI
08056000372465
Brand
Dynamic-static Mixing Tips
Company
ZHERMACK SPA
Model
C205530
Catalog number
C205530
Device description
Dynamic-static Mixing Tips
Published
2025-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
EZHIC2055300PreviousHIBCC0
08056000372298PrimaryGS10
08056000372465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056000372298080560003722988056000372298
08056000372465080560003724658056000372465

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzleA 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
+390425597611info@zhermack.com

Regulatory Flags#

DUNS number
432971034
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZHIC4016101Elite GlassC401610C4016102016-09-09
08056000372298Dynamic-static Mixing TipsC205530C2055302025-03-28
08056000372304Mixing TipsC202085C2020852025-03-28
08056000372311Mixing TipsC202086C2020862025-03-28
08056000372328Mixing TipsC202090C2020902025-03-28
08056000372434Mixing TipsC202085C2020852025-03-28
08056000372441Mixing TipsC202086C2020862025-03-28
08056000372472Mixing TipsC202090C2020902025-03-28
EZHIC3020250hydrogumC302025C3020252016-09-09
EZHIC2007261Occlufast RockC200726C2007262016-09-09
EZHIC2008001Occlufast CadC200800C2008002016-09-09
EZHIC2020201Elite HD+ Monophase Normal SetC202020C2020202016-09-09
EZHIC2020321Elite HD+ Tray Material Fast SetC202032C2020322016-09-09
EZHIC2023201Elite HD+ Maxi Tray Material Fast SetC202320C2023202016-09-09
EZHIC2023301Elite HD+ Maxi Tray Material Fast SetC202330C2023302016-09-09
EZHIC2030000Elite HD+ Putty Soft Normal SetC203000C2030002016-09-09
EZHIC2030021Elite HD+ Putty Soft Normal SetC203002C2030022016-09-09
EZHIC2030100Elite HD+ Putty Soft Fast SetC203010C2030102016-09-09
EZHIC2030121Elite HD+ Putty Soft Fast SetC203012C2030122016-09-09
EZHIC2030201Elite HD+ Regular Body Normal SetC203020C2030202016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10