Model: v07
Catalog: 60042928
DI: 04260482991227
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
CanalPro Jeni Set consist of::
CanalPro Jeni unit, 7" touch display
AC /DC Adapter for US
Wireless-Footswitch,
Motor with ISO-E standard
contra-angle, 1:1, full isolated, ISO-E standard
Apex-cable-set
Retainer for apex-cable
Sterilization
Item #1:
Moist Heat or Steam Sterilization
Item #2:
High-level Disinfectant
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9a261d28-3896-4666-ab27-fdacac205031
Distribution Status:
In Commercial Distribution
DUNS Number:
343831731
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04260482991227
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
LQY
Locator, Root Apex
EKX
Handpiece, Direct Drive, Ac-Powered
Premarket Submissions
Submission Number:
K202906
Supplement Number:
000
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:
40
Storage Handling - Storage Handling Type:
Handling Environment Temperature