GuttaCore Obturators TNSRBGCC00025

GUDID D716TNSRBGCC000250

GuttaCore for RECIPROC Blue R25

TULSA DENTAL PRODUCTS LLC

Natural gutta-percha

• Primary Device ID: D716TNSRBGCC000250
• NIH Device Record Key: b5d517d2-847d-4a5f-9745-17a4451cc28c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GuttaCore Obturators
• Version Model Number: TNSRBGCC00025
• Catalog Number: TNSRBGCC00025
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 30
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716TNSRBGCC000250 [Unit of Use]
HIBCC	D716TNSRBGCC000251 [Primary]

FDA Product Code

• EKM: GUTTA-PERCHA

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [GuttaCore Obturators]

• D716TNSRBGCC000400: GuttaCore for RECIPROC Blue R40
• D716TNSRBGCC000250: GuttaCore for RECIPROC Blue R25
• D716TNSRBGC6000500: GuttaCore for RECIPROC Blue R50
• D716TNSRBGC6000400: GuttaCore for RECIPROC Blue R40
• D716TNSRBGC6000250: GuttaCore for RECIPROC Blue R25