ENA CEM HV CPCBDU

GUDID EMICCPCBDU0

EnaCem HV Universal Transparent 2g Light curing composite

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICCPCBDU0
• NIH Device Record Key: 53d017b0-01ea-4188-9efa-b2e0e9b62500
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENA CEM HV
• Version Model Number: CPCBDU
• Catalog Number: CPCBDU
• 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	EMICCPCBDU0 [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: 2025-04-11
• Device Publish Date: 2025-04-03

On-Brand Devices [ENA CEM HV]

• EMICCPCBKD1: Ena Cem HV 3x2g Light curing Composite + Ena Soft 1g
• EMICCPCBKD0: Ena Cem HV 3x2g Light curing Composite + Ena Soft 1g
• EMICCPCBDU1: EnaCem HV Universal Transparent 2g Light curing composite
• EMICCPCBDU0: EnaCem HV Universal Transparent 2g Light curing composite
• EMICCPCBD41: Ena Cem HV BD4 (A4) 2g Light curing composite
• EMICCPCBD40: Ena Cem HV BD4 (A4) 2g Light curing composite
• EMICCPCBD31: Ena Cem HV BD3 (A3) 2g Light curing composite
• EMICCPCBD30: Ena Cem HV BD3 (A3) 2g Light curing composite
• EMICCPCBD21: Ena Cem HV BD2 (A2) 2g Light curing composite
• EMICCPCBD20: Ena Cem HV BD2 (A2) 2g Light curing composite
• EMICCPCBD10: Ena Cem HV BD0 2g Light curing composite
• EMICCPCBD1: Ena Cem HV BD0 2g Light curing composite
• EMICCPCBD01: Ena Cem HV BD0 2g Light curing composite
• EMICCPCBD00: Ena Cem HV BD0 2g Light curing composite