GuttaCore Obturators

Basic Information

• Brand Name: GuttaCore Obturators
• Primary DI: D716TNSRBGCC000251
• Version / Model: TNSRBGCC00025
• Catalog Number: TNSRBGCC00025
• Company Name: TULSA DENTAL PRODUCTS LLC
• Labeler DUNS: 942778564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 1
• Public Version Date: 2024-04-02
• Public Version Status: New
• Public Device Record Key: b5d517d2-847d-4a5f-9745-17a4451cc28c

Device Description

GuttaCore for RECIPROC Blue R25

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKM	GUTTA-PERCHA	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31872	Natural gutta-percha	A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D716TNSRBGCC000250	HIBCC
Primary	D716TNSRBGCC000251	HIBCC