Triad® 905537

GUDID D0019055370

Dentsply International Inc.

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• Primary Device ID: D0019055370
• NIH Device Record Key: 23c9c9b4-bf17-41d3-a40a-8e018a6ab695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triad®
• Version Model Number: DuaLine® Refill Package
• Catalog Number: 905537
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• Device Count: 2
• 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: 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

Customer Support Contacts

• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsplysirona.com

Device Dimensions

• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0
• Weight: 56 Gram
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0019055368 [Unit of Use]
HIBCC	D0019055370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926406

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-10
• Device Publish Date: 2016-09-21

On-Brand Devices [Triad®]

• D00195768010: Regular Pink Unfibered (Sheets)
• D001957650: VLC Bonding Agent
• D001957580: Regular Pink Fibered (Sheets)
• D001957570: Light Pink Fibered (Sheets)
• D001957510: Regular Pink Fibered (Sheets)
• D001957500: Light Pink Fibered (Sheets)
• D00195745020: Regular Pink Fibered (Sheets)
• D00195745010: Light Pink Fibered (Sheets)
• D00195744020: Regular Pink Fibered (Ropes)
• D00195744010: Light Pink Fibered (Ropes)
• D00195743030: Regular Pink Unfibered (Ropes)
• D00195743020: Regular Pink Fibered (Ropes)
• D00195743010: Light Pink Fibered (Ropes)
• D00195742030: Regular Pink Unfibered (Sheets)
• D00195742020: Regular Pink Fibered (Sheets)
• D00195742010: Light Pink Fibered (Sheets)
• D0019055370: DuaLine® Refill Package
• D0019055300: DuaLine® Introductory Package
• D001901300: Material Sample Kit
• D001899350: Dark Pink Fibered (Sheets)
• D001897810: Regular Pink Unfibered (Sheets)
• D001897800: Regular Pink Fibered (Sheets)
• D001897790: Light Pink Fibered (Sheets)
• D001892760: Pink (Sheets)
• D001892750: Colorless (Sheets)
• D001892740: Pink (Sheets)
• D001892730: Pink (Sheets)
• D001892720: Colorless (Sheets)
• D001892710: Colorless (Sheets)
• D001892440: Accessory Package
• D001889780: Regular Pink Fibered (Sheets)
• D001889770: Regular Pink Fibered (Sheets)
• D001889750: Light Pink Fibered (Sheets)
• D001889261: Light Pink Fibered (Sheets)
• D001888600: Gel Clear Pink
• D001888590: Gel Clear Colorless
• D001887620: Gel Assortment Package
• D001887510: Gel Clear Red
• D001887500: Gel Clear Blue