EXACTA Flow-lc 1-EFB1

GUDID 00815619020208

2g syringe of flowable composite for dental restorations.

EXACTA DENTAL PRODUCTS INC

Dental composite resin

• Primary Device ID: 00815619020208
• NIH Device Record Key: c5304201-88e9-40f2-9896-71bfc820ec59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTA Flow-lc
• Version Model Number: Shade B1
• Catalog Number: 1-EFB1
• Company DUNS: 016325552
• Company Name: EXACTA DENTAL PRODUCTS INC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815619020208 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-17

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