DEVICE: Crown Lok (D798SMCLBK0)

Device Identifier (DI) Information

Crown Lok
SMCLBK
Not in Commercial Distribution
SMCLBK
RELIANCE ORTHODONTIC PRODUCTS INC
D798SMCLBK0
HIBCC
December 21, 2017
1
113170088 *Terms of Use
Crown Lok is intended for use as a cement for metal crowns and orthodontic bands. This is the Self Mixing kit that includes 60 self mixing tips. The adhesive is blue shade.
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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 crown resin A dental resin composite material intended to be used for veneering metallic dental crowns.
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FDA Product Code

[?]
Product Code Product Code Name
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

[?]
Size Type Text
No Device Sizes
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Device Record Status

8bc8877e-763b-4da4-af93-2e845bd6c715
March 29, 2018
2
August 01, 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

[?]
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

[?]
630-773-4009
paulgropi@aol.com
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