PremEco Line Prothetik Color System 1030008

GUDID D7091030008

PremEco Line Prothetik Color System Refill: colour shell 8g

Merz Dental GmbH

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• Primary Device ID: D7091030008
• NIH Device Record Key: 5212e2b4-7a88-4289-95ae-4ebaa82b9f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremEco Line Prothetik Color System
• Version Model Number: Refill: colour shell 8g
• Catalog Number: 1030008
• 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

Device Dimensions

• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram
• Weight: 8 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7091030008 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2018-07-17

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