Forma S 5589

GUDID 00883205037596

Forma Global Syringe Refill A2B - 4g Syringe

ULTRADENT PRODUCTS, INC.

Dental composite resin

• Primary Device ID: 00883205037596
• NIH Device Record Key: b373ec0b-afc6-4146-9ce7-7310ab6119a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Forma S
• Version Model Number: 5589
• Catalog Number: 5589
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205037596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240694

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: 2024-08-21
• Device Publish Date: 2024-08-13

On-Brand Devices [Forma S]

• 00883205039781: Forma Global Syringe Refill C2D - 4g Syringe
• 00883205039774: Forma Global Syringe Refill B1D - 4g Syringe
• 00883205038203: Forma Global Syringe Refill Kit - 4g Syringes
• 00883205037923: Forma Global Compule Refill A2D - 10 x 0.2g Capsules
• 00883205037916: Forma Global Compule Refill A2B - 10 x 0.2g Capsules
• 00883205037909: Forma Global Compule Refill A1E - 10 x 0.2g Capsules
• 00883205037893: Forma Global Compule Refill A1D - 10 x 0.2g Capsules
• 00883205037886: Forma Global Compule Refill A1B - 10 x 0.2g Capsules
• 00883205037862: Forma Global Syringe Refill Opaquer - 4g Syringe
• 00883205037855: Forma Global Syringe Refill BL2 - 4g Syringe
• 00883205037848: Forma Global Syringe Refill BL1 - 4g Syringe
• 00883205037831: Forma Global Syringe Refill XWE - 4g Syringe
• 00883205037817: Forma Global Syringe Refill WE - 4g Syringe
• 00883205037800: Forma Global Syringe Refill WD - 4g Syringe
• 00883205037787: Forma Global Syringe Refill Trans/Incisal - 4g Syringe
• 00883205037695: Forma Global Syringe Refill B1B - 4g Syringe
• 00883205037664: Forma Global Syringe Refill A3E - 4g Syringe
• 00883205037657: Forma Global Syringe Refill A3D - 4g Syringe
• 00883205037640: Forma Global Syringe Refill A3B - 4g Syringe
• 00883205037626: Forma Global Syringe Refill A3.5B - 4g Syringe
• 00883205037619: Forma Global Syringe Refill A2E - 4g Syringe
• 00883205037602: Forma Global Syringe Refill A2D - 4g Syringe
• 00883205037596: Forma Global Syringe Refill A2B - 4g Syringe
• 00883205037589: Forma Global Syringe Refill A1E - 4g Syringe
• 00883205037572: Forma Global Syringe Refill A1D - 4g Syringe
• 00883205037565: Forma Global Syringe Refill A1B - 4g Syringe
• 00883205039767: Forma Global Compule Refill C2D - 10 x 0.2g Capsules
• 00883205039750: Forma Global Compule Refill B1D - 10 x 0.2g Capsules
• 00883205038210: Forma Global Capsule Refill Kit - 0.2g Capsules
• 00883205038197: Forma Global Sample Capsule Kit - 3 x 0.2g Capsules (A2B)
• 00883205038180: Forma Global Compule Refill Opaquer - 10 x 0.2g Capsules
• 00883205038173: Forma Global Compule Refill BL2 - 10 x 0.2g Capsules
• 00883205038166: Forma Global Compule Refill BL1 - 10 x 0.2g Capsules
• 00883205038159: Forma Global Compule Refill XWE - 10 x 0.2g Capsules
• 00883205038135: Forma Global Compule Refill WE - 10 x 0.2g Capsules
• 00883205038128: Forma Global Compule Refill WD - 10 x 0.2g Capsules
• 00883205038104: Forma Global Compule Refill Trans/Incisal - 10 x 0.2g Capsules
• 00883205038012: Forma Global Compule Refill B1B - 10 x 0.2g Capsules
• 00883205037985: Forma Global Compule Refill A3E - 10 x 0.2g Capsules
• 00883205037978: Forma Global Compule Refill A3D - 10 x 0.2g Capsules
• 00883205037961: Forma Global Compule Refill A3B - 10 x 0.2g Capsules
• 00883205037947: Forma Global Compule Refill A3.5B - 10 x 0.2g Capsules
• 00883205037930: Forma Global Compule Refill A2E - 10 x 0.2g Capsules
• 00883205037879: Forma Global Sample Syringe Kit - 1g Syringe (A2B)