DEVICE: Light Bond (D798LCREP0)

Device Identifier (DI) Information

Light Bond
LCREP
In Commercial Distribution
LCREP
RELIANCE ORTHODONTIC PRODUCTS INC
D798LCREP0
HIBCC

1
113170088 *Terms of Use
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 kit contains 4 X 5g LCR Adhesive paste in push syringes, 2 X 3cc Light Bond Sealant, 1 X 23g Etchant and mixing accessories.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C) Avoid excessive heat.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

701e196a-549f-4a72-8657-6a4348f5dca5
March 29, 2018
2
August 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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