EnaCem HF CPCK

GUDID EMICCPCK1

ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle

MICERIUM SPA

Glass ionomer dental cement

• Primary Device ID: EMICCPCK1
• NIH Device Record Key: 2c0e575a-2d55-4f05-8539-122fff2f2338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnaCem HF
• Version Model Number: CPCK
• Catalog Number: CPCK
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCPCK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062355

FDA Product Code

• EMA: Cement, Dental

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: 2021-12-10
• Device Publish Date: 2021-12-02

Devices Manufactured by MICERIUM SPA

• EMICCPC0 - ENA CEM HF: 2025-04-11 DUAL CEMENT ENACEM
• EMICCPC1 - ENA CEM HF: 2025-04-11 DUAL CEMENT ENACEM
• EMICCPC30 - ENA CEM HF: 2025-04-11 ENACEM DUAL CEMENT 3g
• EMICCPC31 - ENA CEM HF: 2025-04-11 ENACEM DUAL CEMENT 3g
• EMICCPC3UD20 - ENA CEM HF: 2025-04-11 ENACEM HF DUAL CEMENT UD2 3g
• EMICCPC3UD21 - ENA CEM HF: 2025-04-11 ENACEM HF DUAL CEMENT UD2 3g
• EMICCPCBD00 - ENA CEM HV: 2025-04-11 Ena Cem HV BD0 2g Light curing composite
• EMICCPCBD01 - ENA CEM HV: 2025-04-11 Ena Cem HV BD0 2g Light curing composite