AccessGUDID - DEVICE: Crown Lok (D798SMCLBK0)

GUDID

Device Identifier (DI) Information

Brand Name: Crown Lok
Version or Model: SMCLBK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SMCLBK
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798SMCLBK0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 21, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8bc8877e-763b-4da4-af93-2e845bd6c715
Public Version Date: October 29, 2018
Public Version Number: 5
DI Record Publish Date: August 01, 2016