PRO Resins Arch X 019.3259

GUDID 04260635981518

PRO Resins Arch X A3.5 1000g

DeltaMed GmbH

Dental appliance fabrication material, combination-material

• Primary Device ID: 04260635981518
• NIH Device Record Key: c31d17f6-984c-4ff3-b9f5-ebd718d917fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO Resins Arch X
• Version Model Number: 019.3259
• Catalog Number: 019.3259
• Company DUNS: 344805101
• Company Name: DeltaMed GmbH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260635981518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243720

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: 2025-02-24
• Device Publish Date: 2025-02-14

On-Brand Devices [PRO Resins Arch X]

• 04260635981549: PRO Resins Arch X C1 1000g
• 04260635981532: PRO Resins Arch X Bleach 1000g
• 04260635981525: PRO Resins Arch X B1 1000g
• 04260635981518: PRO Resins Arch X A3.5 1000g
• 04260635981501: PRO Resins Arch X A3 1000g
• 04260635981495: PRO Resins Arch X A2 1000g
• 04260635981488: PRO Resins Arch X A1 1000g