Diapex Plus A1001-504

GUDID 08806383564717

DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.

DiaDent Group International

Endodontic filling/sealing material

• Primary Device ID: 08806383564717
• NIH Device Record Key: d75731dd-f89b-4404-b27a-93f508b387e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diapex Plus
• Version Model Number: REFILL KIT
• Catalog Number: A1001-504
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383564717 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-22
• Device Publish Date: 2019-08-23

On-Brand Devices [Diapex Plus]

• 08806383564724: DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling m
• 08806383564717: DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling m
• 08806383564700: DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling m
• 08806383564694: Diapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling m
• 08806383564687: Diapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling m