Admira Protect 1652

GUDID E22116521

Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible with a curing light. Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance. Moisture-tolerant. Durable marginal integrity. Easy and fast application - one-coat, one-cure technique. contains fluorides. No refrigerated storage needed. Ideal for paediatric use.

VOCO GmbH

Dental unfilled resin sealant/coating

• Primary Device ID: E22116521
• NIH Device Record Key: c0762cc8-38f7-43eb-854f-bf2156bbbc60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira Protect
• Version Model Number: 1652
• Catalog Number: 1652
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 200
• 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	E22116520 [Unit of Use]
HIBCC	E22116521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061823

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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 Protect]

• E22116521: Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible
• E22116511: Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible
• E22116501: Light-curing self-etch-bond reinforced with nano-fillers. Chemical-curing in areas inaccessible