Custom I Q CIQA

GUDID D798CIQA0

INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.

RELIANCE ORTHODONTIC PRODUCTS INC

Dentine bonding agent/set

• Primary Device ID: D798CIQA0
• NIH Device Record Key: 3b8b555d-24eb-4282-a54d-c060aa1cb22c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Custom I Q
• Version Model Number: CIQA
• Catalog Number: CIQA
• 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: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
• Special Storage Condition, Specify: Between 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798CIQA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880791

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: 2016-07-25

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