Admira Fusion 2764

GUDID E22127641

Universal nanohybrid ORMOCER restorative material.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22127641
• NIH Device Record Key: d3e4c236-da0f-4ab8-93f8-48d0b09ef8e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira Fusion
• Version Model Number: 2764
• Catalog Number: 2764
• Company DUNS: 316699578
• Company Name: VOCO 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: 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	E22127641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150784

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: 2016-08-31

On-Brand Devices [Admira Fusion]

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• E22128061: Universal nanohybrid ORMOCER restorative material.
• E22128041: Universal nanohybrid ORMOCER restorative material.
• E22128031: Universal nanohybrid ORMOCER restorative material.
• E22128011: Universal nanohybrid ORMOCER restorative material.
• E22128001: Universal nanohybrid ORMOCER restorative material.
• E22127991: Universal nanohybrid ORMOCER restorative material.
• E22127981: Universal nanohybrid ORMOCER restorative material.
• E22127961: Universal nanohybrid ORMOCER restorative material.
• E22127941: Universal nanohybrid ORMOCER restorative material.
• E22127921: Universal nanohybrid ORMOCER restorative material.
• E22127911: Universal nanohybrid ORMOCER restorative material.
• E22127901: Universal nanohybrid ORMOCER restorative material.
• E22127881: Universal nanohybrid ORMOCER restorative material.
• E22127871: Universal nanohybrid ORMOCER restorative material.
• E22127861: Universal nanohybrid ORMOCER restorative material.
• E22127851: Universal nanohybrid ORMOCER restorative material.
• E22127841: Universal nanohybrid ORMOCER restorative material.
• E22127831: Universal nanohybrid ORMOCER restorative material.
• E22127821: Universal nanohybrid ORMOCER restorative material.
• E22127811: Universal nanohybrid ORMOCER restorative material.
• E22127801: Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira
• E22127791: Universal nanohybrid ORMOCER restorative material.
• E22127781: trial set
• E22127761: Universal nanohybrid ORMOCER restorative material.
• E22127751: Universal nanohybrid ORMOCER restorative material.
• E22127731: Universal nanohybrid ORMOCER restorative material.
• E22127721: Universal nanohybrid ORMOCER restorative material.
• E22127711: Universal nanohybrid ORMOCER restorative material.
• E22127701: Universal nanohybrid ORMOCER restorative material.
• E22127681: Universal nanohybrid ORMOCER restorative material.
• E22127661: Universal nanohybrid ORMOCER restorative material.
• E22127641: Universal nanohybrid ORMOCER restorative material.
• E22127631: Universal nanohybrid ORMOCER restorative material.
• E22127621: Universal nanohybrid ORMOCER restorative material.
• E22127601: Universal nanohybrid ORMOCER restorative material.
• E22127591: Universal nanohybrid ORMOCER restorative material.
• E22127581: Universal nanohybrid ORMOCER restorative material.
• E22127571: Universal nanohybrid ORMOCER restorative material.
• E22127561: Universal nanohybrid ORMOCER restorative material.
• E22127551: Universal nanohybrid ORMOCER restorative material.
• E22127541: Universal nanohybrid ORMOCER restorative material.
• E22127521: Shade guide.
• E22127511: Universal nanohybrid ORMOCER restorative material.
• E22127501: Universal nanohybrid ORMOCER restorative material. This kit contains different shades of Admira
• E22128050: Universal nanohybrid ORMOCER restorative material.
• E22127771: Universal nanohybrid ORMOCER restorative material.