Chromaclone 5011

GUDID 00883205107671

Chromaclone PVS Heavy Fast Set Refill

ULTRADENT PRODUCTS, INC.

Silicone dental impression material

• Primary Device ID: 00883205107671
• NIH Device Record Key: 9d2e18f5-dedb-49ae-ac48-7e36794d32e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromaclone
• Version Model Number: 5011
• Catalog Number: 5011
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205107671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972027

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Chromaclone]

• 00883205107794: Chromaclone PVS Wash Regular Set Refill
• 00883205107787: Chromaclone PVS Wash Regular Set Econo Refill
• 00883205107770: Chromaclone PVS Wash Fast Set Refill
• 00883205107763: Chromaclone PVS Wash Fast Set Econo Refill
• 00883205107756: Chromaclone PVS Super Light Fast Set Refill
• 00883205107749: Chromaclone PVS Putty
• 00883205107732: Chromaclone PVS Medium Regular Set Refill
• 00883205107725: Chromaclone PVS Medium Regular Set Econo Refill
• 00883205107718: Chromaclone PVS Medium Fast Set Refill
• 00883205107701: Chromaclone PVS Medium Fast Set Econo Refill
• 00883205107695: Chromaclone PVS Heavy Regular Set Refill
• 00883205107688: Chromaclone PVS Heavy Regular Set Econo Refill
• 00883205107671: Chromaclone PVS Heavy Fast Set Refill
• 00883205107664: Chromaclone PVS Heavy Fast Set Econo Refill
• 00883205107657: Chromaclone Ortho 5-day Refill Extra Fast Set
• 00883205107640: Chromaclone Ortho 5-day Kit Extra Fast Set
• 00883205107633: Chromaclone 5-day Bubble Gum Refill Fast Set
• 00883205107626: Chromaclone 5-day Bubble Gum Kit Fast Set
• 00883205033079: Clone Bite Kit
• 00883205033062: Chromaclone PVS Putty