UNIVERSAL 1 CU1OP

GUDID EMICCU1OP1

UNIVERSAL 1 OPAQUE Light curing composite syringe 5 g

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICCU1OP1
• NIH Device Record Key: 323fc231-5bde-4678-8797-b212cda2865f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL 1
• Version Model Number: CU1OP
• Catalog Number: CU1OP
• Company DUNS: 436661136
• Company Name: MICERIUM SPA
• 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: true
• 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
HIBCC	EMICCU1OP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062906

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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [UNIVERSAL 1]

• EMICCU1UN1: UNIVERSAL 1 Light curing composite syringe 5 g
• EMICCU1UN0: UNIVERSAL 1 Light curing composite syringe 5 g
• EMICCU1OP1: UNIVERSAL 1 OPAQUE Light curing composite syringe 5 g
• EMICCU1OP0: UNIVERSAL 1 OPAQUE Light curing composite syringe 5 g
• EMICCU1BF1: UNIVERSAL 1 BULKFILL Light curing composite syringe 2 g
• EMICCU1BF0: UNIVERSAL 1 BULKFILL Light curing composite syringe 2 g
• EMICCHFFB1: CAPO 1 Bulkfill Universal 2g
• EMICCHFFB0: CAPO 1 Bulkfill Universal 2g