Vitique 213080

GUDID EDMG2130801

Cementation system for definitive cementation of veneers. Veneer cementation with added value. Content: 3 syringes @ 6g Esthetic resin cement, 3 syringes @ 3.9 g Try-In-paste, accessories. Resin-based dental luting material. 1 bottle @ 3ml Silane Adhesive, 1 bottle @ 3 ml Silane Activator, 1 bottle @ 5 ml Bond, 1 syringe @ 2 ml Etching Gel, accessories.

DMG Chemisch-Pharmazeutische Fabrik GmbH

Dental etching solution

• Primary Device ID: EDMG2130801
• NIH Device Record Key: 547b794c-c798-49c2-a4e3-ea34681fb055
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitique
• Version Model Number: 213080
• Catalog Number: 213080
• Company DUNS: 320744915
• Company Name: DMG Chemisch-Pharmazeutische Fabrik 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMG2130801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023649

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-14
• Device Publish Date: 2016-09-22

On-Brand Devices [Vitique]

• EDMG2130821: Accessory kit for definitive cementation of veneers. Veneer cementation with added value. Conten
• EDMG2130801: Cementation system for definitive cementation of veneers. Veneer cementation with added value. C
• EDMG2130811: Cementation kit for definitive cementation of veneers. Veneer cementation with added value. Cont
• EDMG2130551: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130541: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130531: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130521: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130511: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130501: Water soluble glycerin-free Try-in-paste. Veneer cementation with added value. Refill: Content:
• EDMG2130491: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130481: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added v
• EDMG2130451: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130441: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130431: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130421: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130411: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130401: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130391: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content:
• EDMG2130381: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content: