Model: 7055-50R
DI: D125705550R4
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Disposable Dynamic Mixing Tips
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
281f49ba-1629-4dca-94f4-d5cc9e34951d
Distribution Status:
In Commercial Distribution
DUNS Number:
541637603
Device Count:
50
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
D125705550R8
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
D125705550R4
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D125705550R4
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
Item #3 - Device ID:
D125705550R0
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 58399
Name: Dental material mixing nozzle
Definition:
A 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.
FDA Product Codes
JDZ
Mixer, Cement, For Clinical Use