AccessGUDID - DEVICE: Crown-Lok (D798CL0)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: D798CL0
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. Crown Lok Kit contains (4) 6gm Screw Paste A Syringes and (4) 6gm Screw Paste B Syringes and a 9gm etch. Crown Lok is a self-curing two minute working time fluoride releasing cement.

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
36153	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin
KLE	Agent, Tooth Bonding, 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: TEMPERATURE LIMITATION: Store at room temperature (15-30 C )

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 461f29cf-d41a-46c4-9b0e-07c8e634adae
Public Version Date: July 24, 2018
Public Version Number: 3
DI Record Publish Date: July 25, 2016