EnaCem Z CPCZK

GUDID EMICCPCZK1

ENACEM Z KIT PRIMER + CEMENT 1 CPCZ ENACEM Z zirconia cement 8g. 1 CPCZP ENACEM Z Primer 5 ml.

MICERIUM SPA

Glass ionomer dental cement

• Primary Device ID: EMICCPCZK1
• NIH Device Record Key: 514f8168-252a-4637-892d-8ed6a97998f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnaCem Z
• Version Model Number: CPCZK
• Catalog Number: CPCZK
• 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: false
• Device Combination Product: true
• 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 Dimensions

• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter
• Weight: 8 Gram
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable
• Handling Environment Temperature: Between 3 Degrees Celsius and 11 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Flammable

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCPCZK1 [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

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• EMICCU1OP0 - UNIVERSAL 1: 2025-04-21 UNIVERSAL 1 OPAQUE Light curing composite syringe 5 g
• EMICCU1OP1 - UNIVERSAL 1: 2025-04-21 UNIVERSAL 1 OPAQUE Light curing composite syringe 5 g
• EMICCU1UN0 - UNIVERSAL 1: 2025-04-21 UNIVERSAL 1 Light curing composite syringe 5 g
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