Device
Reusable dual-component mixing gun used to dispense OPTIWELD dual-cure composite material from standard 5cc mixing cartridges during dental prosthetic procedures.
Manufacturer
DIGITAL ARCHES INC.
DIGITAL ARCHES INC.
Model: N/A
Catalog: OS-WELDER5CC
DI: 00810222551156
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Reusable dual-component mixing gun used to dispense OPTIWELD dual-cure composite material from standard 5cc mixing cartridges during dental prosthetic procedures.
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7f2dcbd1-53c7-49ed-948d-60d35eba2471
Distribution Status:
In Commercial Distribution
DUNS Number:
145248707
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810222551156
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60885
Name: Dental material cartridge-plunging applicator, two-component, manual
Definition:
A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.
FDA Product Codes
EID
Syringe, Restorative And Impression Material