DEVICE: CrownLok (D798CLSAB0)

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Device Record History
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Device Identifier (DI) Information
CrownLok
CLSAB
Not in Commercial Distribution
CLSAB
RELIANCE ORTHODONTIC PRODUCTS INC
D798CLSAB0
HIBCC
May 11, 2026
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. This is 6gm Screw Blue Paste A Syringe
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
38781 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.
Active false
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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

[?]
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
6b7af24b-2686-4315-8080-8696b0161dbf
May 29, 2026
6
September 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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

[?]
6307734009
paulgropi@aol.com
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