Gutta-Smart

Basic Information

• Brand Name: Gutta-Smart
• Primary DI: D716GSMART25G1
• Version / Model: GSMART25G
• Catalog Number: GSMART25G
• Company Name: TULSA DENTAL PRODUCTS LLC
• Labeler DUNS: 942778564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-06-30
• Public Version: 3
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 4110acf3-8816-4f71-b2c1-bf2ac6174eac

Device Description

Gutta-Smart Cartridges with Conform Fit Gutta-Percha, 25G

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKR	PLUGGER, ROOT CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44859	Gutta-percha injector	A hand-held, pistol-shaped, electrically-heated device used to deliver warmed and softened gutta-percha to the dental root canal. Sticks of gutta-percha are inserted into the device and thermally softened before being squeezed out with the ejection trigger through an application tube of varying sizes into the root canal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D716GSMART25G0	HIBCC
Primary	D716GSMART25G1	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: less than 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Specify: Keep away from sunlight.