DEVICE: Crown Lok (D798SMCLB0)

Download: XML | JSON

Device Identifier (DI) Information

Crown Lok
SMCLB
SMCLB
RELIANCE ORTHODONTIC PRODUCTS INC
D798SMCLB0
HIBCC
1
Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands. This is the Self Mixing dispensing in Blue Shade.
CLOSE

Device Characteristics

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

FDA Product Code

[?]
Product Code Product Code Name
EBF Material, Tooth Shade, Resin
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
July 27, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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