CoreTEC

GUDID 00366975000453

Fiber Reinforced Core Build-Up Material; A2 Sample

BENCO DENTAL SUPPLY CO.

Dental composite resin

• Primary Device ID: 00366975000453
• NIH Device Record Key: f8d87149-342f-45fc-9ba8-afb3f6527aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTEC
• Version Model Number: 4276-240
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• Device Count: 1
• DM Exempt: false
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975000453 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-04

On-Brand Devices [CoreTEC]

• 00366975000491: Clear Fiber Post Kit; Refill 1.50 mm
• 00366975000484: Clear Fiber Post Kit; Refill 1.25 mm
• 00366975000477: Clear Fiber Post Kit; Refill 1.00 mm
• 00366975000460: Clear Fiber Post Kit: 30 Clear Parallel Fiber Posts & 3 Drills
• 00366975000453: Fiber Reinforced Core Build-Up Material; A2 Sample
• 00366975000446: Fiber Reinforced Core Build-Up Material; Mixing Tips/Intraoral Tips
• 00366975000439: Clear Fiber Post Refill; Drill Refill; 1.50 mm
• 00366975000422: Clear Fiber Post Refill; Drill Refill; 1.25 mm
• 00366975000415: Clear Fiber Post Refill; Drill Refill; 1.00 mm
• 00366975000408: Fiber Reinforced Core Build-Up Material - Auto-Mix Syringe Kit; White
• 00366975000392: Fiber Reinforced Core Build-Up Material - Auto-Mix Syringe Kit; A2
• 00366975026071: 4753-939
• 00366975026064: 4753-920
• 00366975026057: 4753-911
• 00366975026040: 4753-902
• 00366975026033: 4753-895
• 00366975026026: 4753-886
• 00366975026019: 4753-877
• 00366975026002: 4753-868