DIAFIL A2001-1212

GUDID 08806383565028

DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.

DiaDent Group International

Dental composite resin

• Primary Device ID: 08806383565028
• NIH Device Record Key: 6c5ebb74-47c3-49c8-81a7-7244e45f3a77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAFIL
• Version Model Number: Refill A2O
• Catalog Number: A2001-1212
• 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 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety Information

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383565028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192510

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]

• 08806383564915: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575720: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575713: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575706: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575690: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575683: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575676: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575669: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575652: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575645: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575638: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575621: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383575614: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565134: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565127: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565110: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565103: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565097: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565035: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565028: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565011: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383565004: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564991: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564984: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564977: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564960: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564953: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564946: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564939: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.
• 08806383564922: DiaFil & DiaFil Capsule is a composite resin for esthetic restorative.