Device
Carpules Dispenser Syringe, Blue/White
Manufacturer
PLASDENT CORPORATION
Model: 906CDG3 Catalog: 906CDG3 DI: D832906CDG30 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-01 Current Version: 2026-05-11
Description
Carpules Dispenser Syringe, Blue/White
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 30ad93b1-18db-43e2-b4b7-ad356ec1e63f
Distribution Status: In Commercial Distribution
DUNS Number: 190377184
Device Count: 1
DM Exempt: Yes
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: D832906CDG30
Type: Primary
Issuing Agency: HIBCC
GMDN
Code: 16196
Name: Dental material cartridge-plunging applicator, single-component
Definition:
A hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.
FDA Product Codes
NRD
Unit, Operative Dental, Accessories