Bonding Resin S20AF

GUDID D798S20AF0

Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brackets and appliances. 20g bottle Sealant resin A with fluoride.

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798S20AF0
• NIH Device Record Key: e9d2d460-3e6a-4400-84f2-03ea1156dbf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonding Resin
• Version Model Number: S20AF
• Catalog Number: S20AF
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• Phone: 630-773-4009
• Email: paulgropi@aol.com
• 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°)
• 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°)
• 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°)
• 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°)
• 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°)
• 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°)
• 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°)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 degrees C°)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798S20AF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894565

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: 2016-08-01

On-Brand Devices [Bonding Resin]

• D798S7B0: Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brack
• D798S7AF0: Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brack
• D798S20B0: Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brack
• D798S20AF0: Reliance Bonding Resins are intended for use in direct and indirect bonding of orthodontic brack