Flow Tain FT

GUDID D798FT0

FlowTain™ is a flowable, light cure orthodontic adhesive intended to be used for bonding lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets and appliances. FlowTain™ can also be used for theretention of thermoplastic aligners. This is a 1.5g syringe of Flow Tain and 10 (22 gauge) tips

RELIANCE ORTHODONTIC PRODUCTS INC

Dental composite resin Dental composite resin

• Primary Device ID: D798FT0
• NIH Device Record Key: 5f4e73a6-6a13-454c-8809-9c28df0d1aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow Tain
• Version Model Number: FT
• Catalog Number: FT
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC 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: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C).
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C).

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798FT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083051

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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: 2016-08-10

On-Brand Devices [Flow Tain]

• D798FTLVTIPS1: Flow Tain L.V. Tips are for dispensing paste from the Flow Tain syringe Pack of 10 X 22 gauge ti
• D798FTLV0: FlowTain™ L.V. (Low Viscosity) is a flowable, light cure adhesive intended to be used for ind
• D798FT0: FlowTain™ is a flowable, light cure orthodontic adhesive intended to be used for bonding lingu
• D7981FTLV0: FlowTain™ L.V. (Low Viscosity) is a flowable, light cure adhesive intended to be used for ind
• D7981FT0: FlowTain™ is a flowable, light cure orthodontic adhesive intended to be used for bonding lingu