Titan Flowable Composite - 6 Syringes of A2 Shade

GUDID 00818207020680

Vista Dental

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: 00818207020680
• NIH Device Record Key: 739f3bed-b3d5-450d-8f80-4bc5dd27c53c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan Flowable Composite - 6 Syringes of A2 Shade
• Version Model Number: 90009
• Company DUNS: 036623932
• Company Name: Vista Dental
• 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: true
• 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: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com
• Phone: 262-636-9755
• Email: info@vista-dental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818207020680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062157

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: 2021-02-08
• Device Publish Date: 2021-01-29

Devices Manufactured by Vista Dental

• 10818207024876 - REGEN Bioactive EndoSealer (SS MST Kit): 2024-02-12
• 10818207024838 - Vista MST Visco Tip SS 17mm 50/cup: 2023-10-10
• 10818207024845 - Vista MST Visco Tip SS 22mm 50/cup: 2023-10-10
• 10818207024852 - Vista MST Visco Tip SS 17mm 20/cup: 2023-10-10
• 10818207024869 - Vista MST Visco Tip SS 22mm 20/cup: 2023-10-10
• 10818207024333 - VacuSeal Syringe: 2023-06-19
• 10818207024340 - SmearOFF System (PS System): 2023-06-19
• 10818207024357 - PS System - Chlor-Xtra Plus Bag (40mL): 2023-06-19