ENA CEM HF CPCTUD1

GUDID EMICCPCTUD10

Ena Cem TRY-IN colour BD1/UD1 2g

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICCPCTUD10
• NIH Device Record Key: bc4f9649-998a-44c9-a33a-8606e3cbe285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENA CEM HF
• Version Model Number: CPCTUD1
• Catalog Number: CPCTUD1
• 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 Dimensions

• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram
• Weight: 7 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCPCTUD10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062355

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 HF]

• EMICCPCZ1: ENACEM Z 8g ZIRCONIA SELF CURING CEMENT
• EMICCPCZ0: ENACEM Z 8g ZIRCONIA SELF CURING CEMENT
• EMICCPCUD41: ENACEM HF UD4 DUAL CEMENT 8 g
• EMICCPCUD40: ENACEM HF UD4 DUAL CEMENT 8 g
• EMICCPCUD31: ENACEM HF UD3 DUAL CEMENT 8 g
• EMICCPCUD30: ENACEM HF UD3 DUAL CEMENT 8 g
• EMICCPCUD21: ENACEM HF UD2 DUAL CEMENT 8 g
• EMICCPCUD20: ENACEM HF UD2 DUAL CEMENT 8 g
• EMICCPCUD11: ENACEM HF UD1 DUAL CEMENT 8 g
• EMICCPCUD10: ENACEM HF UD1 DUAL CEMENT 8 g
• EMICCPCTUT0: Ena Cem TRY-IN Universal Transparent colour 2g
• EMICCPCTUD40: Ena Cem TRY-IN colour BD4/ UD4 2g
• EMICCPCTUD30: Ena Cem TRY-IN colour BD3/UD3 2g
• EMICCPCTUD20: Ena Cem TRY-IN colour BD2/UD2 2g
• EMICCPCTUD10: Ena Cem TRY-IN colour BD1/UD1 2g
• EMICCPCTUD00: Ena Cem TRY-IN colour BD0/UD0 2g
• EMICCPCTK1: Kit Ena Cem TRY-IN
• EMICCPC3UD21: ENACEM HF DUAL CEMENT UD2 3g
• EMICCPC3UD20: ENACEM HF DUAL CEMENT UD2 3g
• EMICCPC31: ENACEM DUAL CEMENT 3g
• EMICCPC30: ENACEM DUAL CEMENT 3g
• EMICCPC1: DUAL CEMENT ENACEM
• EMICCPC0: DUAL CEMENT ENACEM