EndoCeramic Root Repair Material

GUDID 10810138823238

Endo Direct LLC

Root canal obturation kit

• Primary Device ID: 10810138823238
• NIH Device Record Key: 9e363651-09f1-4319-8b95-5d1b8db44f2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoCeramic Root Repair Material
• Version Model Number: ECRRM
• Company DUNS: 125216703
• Company Name: Endo Direct LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810138823238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241457

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-29
• Device Publish Date: 2024-10-21

Devices Manufactured by Endo Direct LLC

• 10810138823276 - RC Mix: 2025-03-11
• 10810138823269 - ProShape Orifice Barrier: 2025-01-21
• 10810138823245 - ProShape Path Size 13 21mm: 2024-11-22
• 10810138823252 - ProShape Path Size 13 25mm: 2024-11-22
• 10810138823238 - EndoCeramic Root Repair Material: 2024-10-29
• 10810138823238 - EndoCeramic Root Repair Material: 2024-10-29
• 10810138822736 - ProShape Gutta Percha F1: 2024-08-12
• 10810138822743 - ProShape Gutta Percha F2: 2024-08-12
• 10810138822750 - ProShape Gutta Percha F3: 2024-08-12