Model: 40-400C
DI: D77140400C1
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Dental City Zilch Pumice Paste
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
08e06fbe-bd9a-4259-b35a-a0da70ea658e
Distribution Status:
In Commercial Distribution
DUNS Number:
808371371
Device Count:
200
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
D77140400C0
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D77140400C1
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 45407
Name: Professional dental abrasive material
Definition:
A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.
FDA Product Codes
EJR
Agent, Polishing, Abrasive, Oral Cavity