DiaFil Flow A2001-4117

GUDID 08806383576147

The subject device is a light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed.

DiaDent Group International

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 08806383576147
• NIH Device Record Key: f70463f3-fbde-4859-8415-70501abf2f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaFil Flow
• Version Model Number: Economic Package D2
• Catalog Number: A2001-4117
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383576147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192284

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [DiaFil Flow]

• 08806383576161: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576154: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576147: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576130: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576123: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576116: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576109: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576093: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576086: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576079: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565493: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565486: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565479: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565295: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565288: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565271: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565264: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565257: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565240: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565233: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565226: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565219: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576413: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383565509: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576451: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576444: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576437: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576420: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576406: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576390: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576383: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576376: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576369: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576352: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576345: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576338: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576321: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576314: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576307: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576291: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576284: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576277: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576260: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576253: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576246: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576239: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576222: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576215: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576208: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a
• 08806383576192: The subject device is a light-curved complex resin for aesthetic restoration for both anterior a