Transcend 4731-

GUDID 00883205028136

Transcend Syringe Refill, EN

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205028136
• NIH Device Record Key: 41a1f22e-9251-4f14-9a7a-b4a129731955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcend
• Version Model Number: 4731-
• Catalog Number: 4731-
• 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)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)553-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205028136 [Primary]
GS1	00883205040671 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201795

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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: 2021-10-06
• Device Publish Date: 2021-09-28

On-Brand Devices [Transcend]

• 00883205033680: Transcend Econo Kit (UB) - Singles
• 00883205028433: Transcend Singles Intro Kit
• 00883205028334: Transcend Singles Refill 10pk, UB
• 00883205028327: Transcend Singles Refill 10pk, EW
• 00883205028310: Transcend Singles Refill 10pk, EN
• 00883205028303: Transcend Singles Refill 10pk, B1D
• 00883205028297: Transcend Singles Refill 10pk, A3D
• 00883205028280: Transcend Singles Refill 10pk, A2D
• 00883205028273: Transcend Singles A1D Refill 10pk
• 00883205028259: Transcend Syringe Intro Kit
• 00883205028167: Transcend Econo Kit (UB) - Syringes
• 00883205028150: Transcend Syringe Refill, UB
• 00883205028143: Transcend Syringe Refill,EW
• 00883205028136: Transcend Syringe Refill, EN
• 00883205028129: Transcend Syringe Refill B1D
• 00883205028112: Transcend Syringe Refill, A3D
• 00883205028105: Transcend Syringe Refill, A2D
• 00883205028099: Transcend Syringe A1D Refill
• 00883205023919: Transcend Syringe Sample
• 00883205023902: Transcend Compule Sample