Ena Tender ® ETPT

GUDID EMICETPT0

ENA TENDER PINK TRANSPARENT, 5g

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICETPT0
• NIH Device Record Key: ba2ffd2f-5e48-4c64-867e-fad06dee389f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena Tender ®
• Version Model Number: ETPT
• Catalog Number: ETPT
• 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: 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: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 Gram
• Weight: 20 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	EMICETPT0 [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: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [Ena Tender ®]

• EMICETPKIT1: Ena Tender Pink Kit 4 colours x 2.5 g: Pink (THP), Pink Dark (THPD), Pink Light (THPL), Pink Tra
• EMICETPKIT0: Ena Tender Pink Kit 4 colours x 2.5 g: Pink, Pink Dark, Pink Light, Pink Transparent 1 Pink Past
• EMICETPT1: ENA TENDER PINK TRANSPARENT, 5g
• EMICETPT0: ENA TENDER PINK TRANSPARENT, 5g
• EMICETPL1: ENA TENDER PINK LIGHT, 5g
• EMICETPD1: ENA TENDER PINK DARK, 5g
• EMICETOP1: ENA Tender paste opaque pink 3g
• EMICETOL1: ENA TENDER PASTE OPAQUE light, 3g
• EMICETOD1: ENA TENDER PASTE OPAQUE dark, 3g