DEVICE: Crown-Lok (D798CLB0)

Device Identifier (DI) Information

Crown-Lok
CLB
In Commercial Distribution
CLB
RELIANCE ORTHODONTIC PRODUCTS INC
D798CLB0
HIBCC

1
113170088 *Terms of Use
Crown Lok™ Blue is intended for use as a cement for metal crowns and orthodontic bands. Crown Lok is a self-curing two minute working time fluoride releasing cement. Crown Lok Kit contains (4) 6gm Screw Blue Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Dental etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
Dental prosthesis veneer resin A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.
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FDA Product Code

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Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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 C)
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

83a283b4-de5d-4ba6-984d-f145390beefa
July 24, 2018
3
July 25, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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