FDA.reportPublic FDA data

Dynamic Mixing Tips

Primary DI
00850211006229
Brand
Dynamic Mixing Tips
Company
HO DENTAL COMPANY LLC
Model
Vacu-Mixer Tip
Device description
Dynamic Mixing Tips to be used only with the Vacu-Mixer Automated Mixing Machine,50/bag
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850211006229PrimaryGS10
00850211006458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850211006229008502110062298502110062290850211006229
00850211006458008502110064588502110064580850211006458

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

Regulatory Flags#

DUNS number
012676012
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850211006144Facial Plane RelatorFPR-1022023-05-17
00850211006021Vaccu-sil VPS Heavy Body 50 Impression MaterialRegular Set2017-10-10
00850211006038Vaccu-sil VPS Heavy Body 50 Impression MaterialFast Set2017-10-10
00850211006045Vaccu-sil VPS Light Body CartridgeFast Set2017-10-10
00850211006052Vaccu-sil VPS Light Body CartridgeRegular Set2017-10-10
00850211006083Harmony Anterior Disposable Dual Arch TrayAnterior2017-10-10
00850211006090Harmony Posterior Disposable Dual Arch TryPosterior2017-10-10
00850211006205Vacu-Mixer Automated VPS Mixing MachineVacu-Mixer2017-10-10
00850211006212Mojo VPS Light Body Impression SyringeEmpty2017-10-10
00850211006236Vaccu-sil VPS Heavy Body 120 Impression MaterialFast Set2017-10-10
00850211006243Vaccu-sil VPS Heavy Body 120 Impression MaterialRegular Set2017-10-10
00850211006250Vaccu-sil Bite RegistrationRegular Set2017-10-10
00850211006267Vaccu-Sil Mojo Complete Light Body SyringeRegular Set2017-10-10
00850211006274Vaccu-Sil Mojo Complete Light Body SyringeFast Set2017-10-10
00850211006311VacuCord Gingival Retraction CordSize 002017-10-11
00850211006328VacCord Gingival Retraction CordSize 02017-10-11
00850211006335VacuCord Gingival Retraction CordSize 12017-10-11
00850211006342VacuCord Gingival Retraction CordSize 22017-10-11

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