Nexcomp Unidose OP

GUDID 08806387892755

Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide.

Meta Biomed Co., Ltd.

Dental composite resin

• Primary Device ID: 08806387892755
• NIH Device Record Key: d0936ac1-228a-4499-9aeb-c082f5d2d74d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexcomp Unidose OP
• Version Model Number: 9275
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387892755 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-18
• Device Publish Date: 2016-09-19

On-Brand Devices [Nexcomp Unidose OP]

• 08806387894735: Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a
• 08806387892755: Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a