Admira Fusion Flow 2817

GUDID E22128171

Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)

VOCO GmbH

Dental composite resin

• Primary Device ID: E22128171
• NIH Device Record Key: 82f6181c-2530-4d27-ae2b-6e7cc86dc00b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira Fusion Flow
• Version Model Number: 2817
• Catalog Number: 2817
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 5
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22128170 [Unit of Use]
HIBCC	E22128171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153177

FDA Product Code

• EBF: Material, Tooth Shade, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-31

On-Brand Devices [Admira Fusion Flow]

• E22128321: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128311: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128291: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128281: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128261: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128251: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128241: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128221: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128211: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128201: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128191: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128181: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128171: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic)
• E22128161: Flowable light-cured Nano-Hybrid Ormocer (ORganically-MOdified CERamic) Kit: 5 × 2 g syringes (