Admira Protect

Basic Information

• Brand Name: Admira Protect
• Primary DI: E22116521
• Version / Model: 1652
• Catalog Number: 1652
• Company Name: VOCO GmbH
• Labeler DUNS: 316699578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c0762cc8-38f7-43eb-854f-bf2156bbbc60

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	872.3765	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E22116521	HIBCC
Unit of Use	E22116520	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061823	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 23 Degrees Celsius