Excel SMEF

GUDID D798SMEF0

Excel Adhesives are intended for use as an orthodontic bonding adhesive for brackets and appliances. This is the Fast Set, self mixing syringe delivery system.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive

• Primary Device ID: D798SMEF0
• NIH Device Record Key: eb9ccddf-892a-4841-b09d-f1308690651d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excel
• Version Model Number: SMEF
• Catalog Number: SMEF
• 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 / not to exceed 86 Degree F)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C / not to exceed 86 Degree F)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798SMEF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K875144

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: 2016-07-27

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