PermaShade Try-In Paste 5778

GUDID 00883205027962

PermaShade Try-In Paste Opaque White Refill

ULTRADENT PRODUCTS, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 00883205027962
• NIH Device Record Key: 37326fff-7bc7-4fad-97b9-a6631b929a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermaShade Try-In Paste
• Version Model Number: 5778
• Catalog Number: 5778
• 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: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205027962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111836

FDA Product Code

• EMA: Cement, Dental

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: 2024-01-19
• Device Publish Date: 2024-01-11

On-Brand Devices [PermaShade Try-In Paste]

• 00883205027986: PermaShade Try-In Paste B1 Refill
• 00883205027979: PermaShade Try-In Paste A2 Refill
• 00883205027962: PermaShade Try-In Paste Opaque White Refill
• 00883205027955: PermaShade Try-In Paste Translucent Refill
• 00883205027948: PermaShade Try-In Paste Kit