P pro Try-In 019.3117

GUDID 04260635980207

P pro Try-In 1000g

DeltaMed GmbH

Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate Dental base plate

• Primary Device ID: 04260635980207
• NIH Device Record Key: e37dbbd0-f8b3-44db-83f1-4d9a026abfd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P pro Try-In
• Version Model Number: 019.3117
• Catalog Number: 019.3117
• Company DUNS: 344805101
• Company Name: DeltaMed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260635980207 [Primary]

FDA Product Code

• EEA: Plate, Base, Shellac

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: 2022-02-21
• Device Publish Date: 2022-02-11

Devices Manufactured by DeltaMed GmbH

• EDEL16110100 - 3Delta Etemp: 2023-09-25 3Delta Etemp A1, 1000g
• EDEL16110200 - 3Delta Etemp: 2023-09-25 3Delta Etemp A2, 1000g
• EDEL16110300 - 3Delta Etemp: 2023-09-25 3Delta Etemp A3, 1000g
• EDEL3011OP0 - Renamel® Flowable Microfill: 2023-09-22 Renamel® Flowable Microfill OPAL™, Syringe 3g
• EDEL6071OP0 - Renamel® Microfill: 2023-09-22 Renamel® Microfill OPALITE™, Syringe 4g
• EDEL13700100 - DELTASPLINT: 2023-07-07 DELTASPLINT, 12 Rods
• EDEL13700200 - DELTABOND: 2023-07-07 DELTABOND, Bottle 10ml
• EDEL13700300 - DELTAGLACE: 2023-07-07 DELTAGLACE, Bottle 10ml