Metal Primer ME

GUDID D798ME0

Reliance Metal Primer is intended for use as a conditioner of metal surfaces for bonding with an adhesive.

RELIANCE ORTHODONTIC PRODUCTS INC

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• Primary Device ID: D798ME0
• NIH Device Record Key: 3b7528c3-2abc-445d-a2f7-0baca20d8dba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metal Primer
• Version Model Number: ME
• Catalog Number: ME
• 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
• 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	D798ME0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880766

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: 2016-08-03

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• D798RBTA0 - Tweezers: 2023-12-21
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• D798RBX0 - ReliaBox: 2023-12-21 ReliaBox
• D798RBXK0 - ReliaBox: 2023-12-21 ReliaBox Kit
• D7981BEGSSAM0 - Gel Etchant: 2023-09-27
• D7981EGSSAM0 - Gel Etchant: 2023-09-27
• D7981RWX0 - ReliaWax: 2023-09-27