Light Cure Retainer LCRT5

GUDID D798LCRT51

L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for retention of thermoplastic aligners. This product is 5g LCR paste in 11 individual dispensing tips.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798LCRT51
• NIH Device Record Key: a6a1ba72-36d7-4882-aaa7-004ef3080264
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Cure Retainer
• Version Model Number: LCRT5
• Catalog Number: LCRT5
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 11
• DM Exempt: true
• 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: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.com
• Phone: 6307734009
• Email: regulatory@relianceorthodontics.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)
• 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	D798LCRT50 [Unit of Use]
HIBCC	D798LCRT51 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894564

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin
• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2016-08-06

On-Brand Devices [Light Cure Retainer]

• D798LCRT51: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCRETAS0: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCRET0: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCREPPLUS0: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCREPAS0: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCR150: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D798LCR0: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
• D7981LCR150: L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic