Device
One-Fil Putty is an endodontic sealing material designed to provide a biocompatible and effective seal for root canal filling.
Manufacturer
MEDICLUS CO.,LTD
MEDICLUS CO.,LTD
Model: 509-2 One-Fil Putty
Catalog: EC2501001
DI: 08809518343706
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
One-Fil Putty is an endodontic sealing material designed to provide a biocompatible and effective seal for root canal filling.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6a749f10-9255-48ce-a856-c80f51149773
Distribution Status:
In Commercial Distribution
DUNS Number:
688304449
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08809518343706
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60510
Name: Hygroscopic dental cement
Definition:
A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.
FDA Product Codes
KIF
Resin, Root Canal Filling
Premarket Submissions
Submission Number:
K243353
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gram
Device Size - Size - @attributes - Value:
0.25
Device Size - Size Type:
Weight
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Handling Environment Temperature