Enamel Plus Temp ® TEMP1N

GUDID EMICTEMP1N1

ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMP50BLUE, BLUE 50G POWDER - 1 TEMP50UD2, UD2 50g POWDER - 1 TEMP50UD3, UD3 50g POWDER - 1 TEMP50UD3,5 UD3.5 50g POWDER - 1 TEMP50UD4, UD4 50g POWDER - 1 TEMP50UE2, UE2 50g POWDER

MICERIUM SPA

Dental acrylic resin

• Primary Device ID: EMICTEMP1N1
• NIH Device Record Key: db908a51-b11c-440a-a2a1-9e826ce2cec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamel Plus Temp ®
• Version Model Number: TEMP1N
• Catalog Number: TEMP1N
• 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: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram
• Weight: 400 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICTEMP1N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103474

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2021-12-10
• Device Publish Date: 2021-12-02

On-Brand Devices [Enamel Plus Temp ®]

• EMICTEMPL1: ENAMEL PLUS TEMP TEMPL Self Curing 100 ml Liquid
• EMICTEMP1NOF1: ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMP1-CLEAR; TEMP CLEAR 10g - 1 TEMP1-DOD; TEMP DOD 10g -
• EMICTEMP1N1: ENAMEL PLUS TEMP INTRODUCTORY KIT - 1 TEMPL Self Curing 100 ml Liquid - 1 TEMP50BLUE, BLUE 50G P
• EMICTEMPUD31: Enamel Plus Temp UD3, 100g
• EMICTEMPUD21: Enamel Plus Temp UD2, 100g
• EMICTEMPUD11: Enamel Plus Temp UD1