Excel ERJF

GUDID D798ERJF0

Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regular Kit contains 12 gm Excel Regular Paste A with Fluoride in jar, 12 gm Excel Regular Paste B in Jar, 7g Bonding Resin A with Fluoride & 7gm Bonding Resin B, 9 gm Liquid Etchant and mixing accessories . Contains fluoride.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798ERJF0
• NIH Device Record Key: a0630673-f27f-499d-8c3c-bf1bdf4efa22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excel
• Version Model Number: ERJF
• Catalog Number: ERJF
• 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: true
• 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

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)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798ERJF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875141

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: 2016-08-17

On-Brand Devices [Excel]

• D798SMEF0: Excel Adhesives are intended for use as an orthodontic bonding adhesive for brackets and applia
• D798ERSF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regula
• D798ERJF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regula
• D798ERJB0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This is a12g Exce
• D798ERJAF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This is the 12g E
• D798ERBSF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Kit contains
• D798ERBJF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regul
• D798ERBJAF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This is the 12g E
• D798EHSF0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Kit contains
• D798EHJF0: Excel Herbst Kit is intended for use as an orthodontic bonding adhesive for large acrylic applia
• D798EFJB0: FAST SET (60 second working time): Excel is intended for use as an orthodontic bonding adhesive
• D798EFJAF0: FAST SET (60 second working time): Excel is intended for use as an orthodontic bonding adhesive
• D7981ERSB0: For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a
• D7981ERSAF0: For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a
• D7981ERBSAF0: For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a
• D798EUERS0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regula
• D798EUERJ0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This Excel Regula
• D798ERJA0: Excel is intended for use as an orthodontic bonding adhesive for appliances. This is the 12g E
• D7981ERSA0: For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a