FDA.reportPublic FDA data

Health-Tec/DHP Mixing Tips

Primary DI
D773300100061
Brand
Health-Tec/DHP Mixing Tips
Company
Dental Health Products Inc
Model
300-10006
Catalog number
300-10006
Device description
Health-Tec/DHP Dynamic Mixing Tips Yellow 50/pkg
Published
2022-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D773300100061PrimaryHIBCC0

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
623191194
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D773210HT40A121DHP Nanohybrid Composite210-HT40A12210-HT40A122022-10-20
D773210HT40A221DHP Nanohybrid Composite210-HT40A22210-HT40A222022-10-20
D773210HT40A321DHP Nanohybrid Composite210-HT40A32210-HT40A322022-10-20
D773210HT40A3521DHP Nanohybrid Composite210-HT40A352210-HT40A3522022-10-20
D773210HT40B121DHP Nanohybrid Composite210-HT40B12210-HT40B122022-10-20
D773210HT40B221DHP Nanohybrid Composite210-HT40B22210-HT40B222022-10-20
D773210HT40C221DHP Nanohybrid Composite210-HT40C22210-HT40C222022-10-20
D773210HT40C321DHP Nanohybrid Composite210-HT40C32210-HT40C322022-10-20
D773210HT50A120DHP Nanohybrid Composite210-HT50A12210-HT50A122022-10-20
D773210HT50A220DHP Nanohybrid Composite210-HT50A22210-HT50A222022-10-20
D773210HT50A320DHP Nanohybrid Composite210-HT50A32210-HT50A322022-10-20
D773210HT50A3520DHP Nanohybrid Composite210-HT50A352210-HT50A3522022-10-20
D773210HT50B120DHP Nanohybrid Composite210-HT50B12210-HT50B122022-10-20
D773210HT50C320DHP Nanohybrid Composite210-HT50C32210-HT50C322022-10-20
D773210HT10A121DHP Nanohybrid Flowable Composite210-HT10A12210-HT10A122022-10-19
D773210HT10A221DHP Nanohybrid Flowable Composite210-HT10A22210-HT10A222022-10-19
D773210HT10A321DHP Nanohybrid Flowable Composite210-HT10A32210-HT10A322022-10-19
D773210HT10A3521DHP Nanohybrid Flowable Composite210-HT10A352210-HT10A3522022-10-19
D773210HT10A421DHP Nanohybrid Flowable Composite210-HT10A42210-HT10A422022-10-19
D773210HT10B121DHP Nanohybrid Flowable Composite210-HT10B12210-HT10B122022-10-19

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