Nexcomp Flow intro Kit

GUDID 08806387860006

Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin. (A2-A3-A3-A3.5-A3.5)

Meta Biomed Co., Ltd.

Dental composite resin

• Primary Device ID: 08806387860006
• NIH Device Record Key: 74670b0b-16c7-4f03-bc49-385af7083c31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexcomp Flow intro Kit
• Version Model Number: 6000
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• 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: true
• 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	08806387860006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080305

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: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [Nexcomp Flow intro Kit]

• 08806387894995: Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowa
• 08806387894988: Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowa
• 08806387860013: Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowa
• 08806387860006: Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowa