Vit-l-escence 343

GUDID 00883205105530

Vit-l-escence Syringe A2 Refill

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205105530
• NIH Device Record Key: da671c43-0451-422e-9dd7-2320d1f0f6ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vit-l-escence
• Version Model Number: 343
• Catalog Number: 343
• 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: false
• 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 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205105530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974282

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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 [Vit-l-escence]

• 00883205106728: Vit-l-escence Essentials Kit
• 00883205106513: Vit-l-escence Singles Iridescent Blue
• 00883205106506: Vit-l-escence Singles Trans Amber
• 00883205106490: Vit-l-escence Singles Trans Yellow
• 00883205106483: Vit-l-escence Singles Trans Ice
• 00883205106476: Vit-l-escence Singles Trans Gray
• 00883205106469: Vit-l-escence Singles Trans Orange
• 00883205106452: Vit-l-escence Singles Trans Blue
• 00883205106445: Vit-l-escence Singles Trans Smoke
• 00883205106438: Vit-l-escence Singles Trans Mist
• 00883205106421: Vit-l-escence Singles Trans Frost
• 00883205106414: Vit-l-escence Singles Opaque White
• 00883205106407: Vit-l-escence Singles D3
• 00883205106391: Vit-l-escence Singles C5
• 00883205106384: Vit-l-esence Singles C4
• 00883205106377: Vit-l-esence Singles B5
• 00883205106360: Vit-l-esence Singles B4
• 00883205106353: Vit-l-esence Singles B3
• 00883205106346: Vit-l-esence Singles A6
• 00883205106339: Vit-l-escence Singles A5
• 00883205106216: Vit-l-escence Syringe Iridescent Blue Refill
• 00883205106193: Vit-l-escence Singles C3
• 00883205106186: Vit-l-escence Singles C2
• 00883205106179: Vit-l-escence Singles C1
• 00883205106162: Vit-l-escence Singles B2
• 00883205106155: Vit-l-escence Singles A4
• 00883205106148: Vit-l-escence Singles A1
• 00883205106131: Vit-l-escence Singles Opaque Snow
• 00883205106124: Vit-l-escence Singles Pearl Amber
• 00883205106117: Vit-l-escence Singles B1
• 00883205106100: Vit-l-escence Singles A3.5
• 00883205106094: Vit-l-escence Singles A3
• 00883205106087: Vit-l-escence Singles A2
• 00883205106070: Vit-l-escence Singles Pearl Smoke
• 00883205106063: Vit-l-escence Singles Pearl Neutral
• 00883205106056: Vit-l-escence Singles Pearl Frost
• 00883205106049: Vit-l-escence Singles Kit
• 00883205106032: Vit-l-escence Syringe Trans Orange Refill
• 00883205106025: Vit-l-escence Syringe Trans Blue Refill
• 00883205106018: Vit-l-escence Syringe Trans Frost Refill
• 00883205106001: Vit-l-escence Syringe Pearl Smoke Refill
• 00883205105998: Vit-l-escence Syringe Pearl Amber Refill
• 00883205105981: Vit-l-escence Syringe Pearl Neutral Refill
• 00883205105974: Vit-l-escence Syringe Opaque Snow Refill
• 00883205105967: Vit-l-escence Syringe Opaque White Refill
• 00883205105813: Vit-l-escence Advanced Kit
• 00883205105806: Vit-l-escence Syringe Trans Amber Refill
• 00883205105790: Vit-l-escence Syringe Trans Yellow Refill
• 00883205105783: Vit-l-escence Syringe Trans Smoke Refill
• 00883205105776: Vit-l-escence Syringe Trans Mist Refill