Admira 2454

GUDID E22124541

Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (ormocers). Admira is suitable for restorations in both anterior and posterior teeth.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22124541
• NIH Device Record Key: 0da164bf-3ebc-4b8a-bbea-9bba3400ca61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira
• Version Model Number: 2454
• Catalog Number: 2454
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 25
• 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	E22124540 [Unit of Use]
HIBCC	E22124541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061823

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]

• E22124541: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124531: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124521: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124511: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124371: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124311: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124301: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124291: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124281: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124271: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124261: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124251: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124241: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124231: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124221: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124211: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o
• E22124201: Admira is a universal, light-curing restorative material based on 3-dimensionally co-polymers (o