OptiComp

GUDID 00815967021438

OptiComp Universal Restorative Resin-Based Composites, LC 1 x Syringe, enamel refill, 4gm, B3

Pac-Dent, Inc.

Dental composite resin

• Primary Device ID: 00815967021438
• NIH Device Record Key: c8c40df8-4e77-4da7-9ab5-786255ee63e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiComp
• Version Model Number: 8009
• Company DUNS: 080104787
• Company Name: Pac-Dent, 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: true
• 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	00815967021438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202920

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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [OptiComp]

• 00815967021797: OptiComp Nano 4 x 4gm Syringe Refill Shade A3
• 00815967021438: OptiComp Universal Restorative Resin-Based Composites, LC 1 x Syringe, enamel refill, 4gm, B3