Enamel Plus Temp ® TEMPL

GUDID EMICTEMPL1

ENAMEL PLUS TEMP TEMPL Self Curing 100 ml Liquid

MICERIUM SPA

Dental acrylic resin

• Primary Device ID: EMICTEMPL1
• NIH Device Record Key: 8bd5cb47-63a4-4f91-83a9-75c484fdea22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamel Plus Temp ®
• Version Model Number: TEMPL
• Catalog Number: TEMPL
• 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

• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter
• Total Volume: 100 Milliliter

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	EMICTEMPL1 [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: 2021-02-22
• Device Publish Date: 2021-02-12

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