PremEco Line Prothetik Color System 1030073

GUDID D7091030073

PremEco Line Prothetik Color System, Monomer 1000ml

Merz Dental GmbH

Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin

• Primary Device ID: D7091030073
• NIH Device Record Key: 64e0c70a-0a8d-4065-9ba5-bcf7e7322a06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremEco Line Prothetik Color System
• Version Model Number: PremEco Line, Monomer, 1000ml
• Catalog Number: 1030073
• Company DUNS: 324914910
• Company Name: Merz Dental GmbH
• 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: false
• 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

Customer Support Contacts

• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091030073 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130076

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2019-09-13
• Device Publish Date: 2019-09-05

On-Brand Devices [PremEco Line Prothetik Color System]

• D7091030089: PremEco Line Prothetik Color System, Monomer 100ml
• D7091030073: PremEco Line Prothetik Color System, Monomer 1000ml
• D7091030085: PremEco Line Prothetik Color System Refill: colour anemone 100g
• D7091030083: PremEco Line Prothetik Color System Refill: colour coral 100g
• D7091030082: PremEco Line Prothetik Color System Refill: colour shell 100g
• D7091030074: PremEco Line Prothetik Color System Set 1
• D7091030019: Prem EcoLine Prothetik Color System Set 2
• D7091030016: PremEco Line Prothetik Color System Refill: colour anemone 35g
• D7091030015: PremEco Line Prothetik Color System Refill: colour coral 35g
• D7091030014: PremEco Line Prothetik Color System Refill: colour shell 35g
• D7091030013: PremEco Line Prothetik Color System Refill: colour sapphire 8g
• D7091030012: PremEco Line Prothetik Color System Refill: colour ruby 8g
• D7091030011: PremEco Line Prothetik Color System Refill: colour topaz 8g
• D7091030010: PremEco Line Prothetik Color System Refill: colour opal 8g
• D7091030009: PremEco Line Prothetik Color System Refill: colour coral 8g
• D7091030008: PremEco Line Prothetik Color System Refill: colour shell 8g
• D7091030007: PremEco Line Prothetik Color System Refill: colour anemone 8g