Model: GP-Cut
DI: 04719871630303
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
17ff4bb8-3b57-41cb-850c-10ca5a0517a7
Distribution Status:
In Commercial Distribution
DUNS Number:
656330482
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
04719871630303
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67054
Name: Gutta percha cutter
Definition:
An electrically-powered, hand-held device intended to be used to cut gutta percha pins inserted into the root canal of a tooth. It is typically a hand-held device with a thermoelectric wire (e.g., nickel-chromium alloy) at the distal end which delivers heat to cut the gutta percha. It might in addition provide the heat necessary to condense the gutta percha to seal the root canal.
FDA Product Codes
EKD
Instrument, Cutting, Operative