Model: 508-1 One-Fil
Catalog: EC2501001
DI: 08809518341252
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 is a permanent sealing of root canal.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d17b3b0d-0fe6-43b4-898f-b2cf37ff070c
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:
08809518341252
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:
K232182
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Gram
Device Size - Size - @attributes - Value:
2
Device Size - Size Type:
Weight
Environmental Conditions
Storage Handling - Storage Handling Type:
Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text:
Store at a temperature between 15°C and 25°C. This product is sensitive to humidity, so keep the syringe cap tightly closed when not in use.