3Delta UNlimited 1613130

GUDID EDEL16131300

3Delta UNlimited A3 500g

DeltaMed GmbH

Dental appliance fabrication material, resin

• Primary Device ID: EDEL16131300
• NIH Device Record Key: 48597390-a785-42d3-8ae9-36c1da8fb202
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Delta UNlimited
• Version Model Number: 1613130
• Catalog Number: 1613130
• 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: 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 *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
HIBCC	EDEL16131300 [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: 2025-03-24
• Device Publish Date: 2025-03-14

On-Brand Devices [3Delta UNlimited]

• EDEL16132600: 3Delta UNlimited C1 1000g
• EDEL16132550: 3Delta UNlimited B1 1000g
• EDEL16132500: 3Delta UNlimited Bleach 1000g
• EDEL16132350: 3Delta UNlimited A3.5 1000g
• EDEL16132300: 3Delta UNlimited A3 1000g
• EDEL16132200: 3Delta UNlimited A2 1000g
• EDEL16132100: 3Delta UNlimited A1 1000g
• EDEL16131600: 3Delta UNlimited C1 500g
• EDEL16131550: 3Delta UNlimited B1 500g
• EDEL16131500: 3Delta UNlimited Bleach 500g
• EDEL16131350: 3Delta UNlimited A3.5 500g
• EDEL16131300: 3Delta UNlimited A3 500g
• EDEL16131200: 3Delta UNlimited A2 500g
• EDEL16131100: 3Delta UNlimited A1 500g