DiaFil Flow A2001-4216

GUDID 08806383576239

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

• Primary Device ID: 08806383576239
• NIH Device Record Key: 97358c3a-3aa4-424a-8255-2ac24abe93eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiaFil Flow
• Version Model Number: Refill Package D1
• Catalog Number: A2001-4216
• 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	08806383576239 [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: 2020-05-05
• Device Publish Date: 2020-04-27

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