EdgeEndo

GUDID 80810213810114

EdgeUtopia K-File, Size 15, 21mm

HSG-S Corp.

Manual endodontic file/rasp, single-use

• Primary Device ID: 80810213810114
• NIH Device Record Key: bf4a0a0e-d0c9-4084-ad1c-20fbd6c20fca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeEndo
• Version Model Number: EUKF1521
• Company DUNS: 144949235
• Company Name: HSG-S Corp.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810213810118 [Primary]
GS1	80810213810114 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [EdgeEndo]

• 80810213812972: EdgeOnyx, x-Find: Size 09.09 -15mm, x-Follow: Size 15.04 - 21mm, x-Finish: Size 20.04, 25.04, 30
• 80810213812965: EdgeOnyx, x-Find: Size 09.09 -15mm, x-Follow: Size 15.04 - 25mm, x-Finish: Size 20.04, 25.04, 30
• 80810213812958: EdgeOnyx, x-Find, Size 09.09, 15mm
• 80810213810565: EdgeOnyx, x-Finish, Size 45.04, 25mm
• 80810213810558: EdgeOnyx, x-Finish, Size 45.04, 21mm
• 80810213810541: EdgeOnyx, x-Finish, Size 40.04, 25mm
• 80810213810534: EdgeOnyx, x-Finish, Size 40.04, 21mm
• 80810213810527: EdgeOnyx, x-Finish, Size 35.04, 25mm
• 80810213810510: EdgeOnyx, x-Finish, Size 35.04, 21mm
• 80810213810503: EdgeOnyx, x-Finish, Size 30.04, 25mm
• 80810213810497: EdgeOnyx, x-Finish, Size 30.04, 21mm
• 80810213810480: EdgeOnyx, x-Finish, Size 25.04, 25mm
• 80810213810473: EdgeOnyx, x-Finish, Size 25.04, 21mm
• 80810213810466: EdgeOnyx, x-Finish, Size 20.04, 25mm
• 80810213810459: EdgeOnyx, x-Finish, Size 20.04, 21mm
• 80810213810442: EdgeOnyx, x-Follow, Size 17.04, 25mm
• 80810213810435: EdgeOnyx, x-Follow, Size 17.04, 21mm
• 80810213810428: EdgeOnyx, x-Follow, Size 15.04, 25mm
• 80810213810411: EdgeOnyx, x-Follow, Size 15.04, 21mm
• 80810213810398: EdgeUtopia K-File, Size 10-35, 25mm
• 80810213810381: EdgeUtopia K-File, Size 80, 25mm
• 80810213810374: EdgeUtopia K-File, Size 70, 25mm
• 80810213810367: EdgeUtopia K-File, Size 60, 25mm
• 80810213810350: EdgeUtopia K-File, Size 55, 25mm
• 80810213810343: EdgeUtopia K-File, Size 50, 25mm
• 80810213810336: EdgeUtopia K-File, Size 45, 25mm
• 80810213810329: EdgeUtopia K-File, Size 40, 25mm
• 80810213810312: EdgeUtopia K-File, Size 35, 25mm
• 80810213810305: EdgeUtopia K-File, Size 30, 25mm
• 80810213810299: EdgeUtopia K-File, Size 25, 25mm
• 80810213810282: EdgeUtopia K-File, Size 20, 25mm
• 80810213810275: EdgeUtopia K-File, Size 15, 25mm
• 80810213810268: EdgeUtopia K-File, Size 10, 25mm
• 80810213810251: EdgeUtopia K-File, Size 8, 25mm
• 80810213810244: EdgeUtopia K-File, Size 6, 25mm
• 80810213810237: EdgeUtopia K-File, Size 10-35, 21mm
• 80810213810220: EdgeUtopia K-File, Size 80, 21mm
• 80810213810213: EdgeUtopia K-File, Size 70, 21mm
• 80810213810206: EdgeUtopia K-File, Size 60, 21mm
• 80810213810190: EdgeUtopia K-File, Size 55, 21mm
• 80810213810183: EdgeUtopia K-File, Size 50, 21mm
• 80810213810176: EdgeUtopia K-File, Size 45, 21mm
• 80810213810169: EdgeUtopia K-File, Size 40, 21mm
• 80810213810152: EdgeUtopia K-File, Size 35, 21mm
• 80810213810145: EdgeUtopia K-File, Size 30, 21mm
• 80810213810138: EdgeUtopia K-File, Size 25, 21mm
• 80810213810121: EdgeUtopia K-File, Size 20, 21mm
• 80810213810114: EdgeUtopia K-File, Size 15, 21mm
• 80810213810107: EdgeUtopia K-File, Size 10, 21mm
• 80810213810091: EdgeUtopia K-File, Size 8, 21mm