AccessGUDID - DEVICE: CliXdish™ (D0026930061)

GUDID

Device Identifier (DI) Information

Brand Name: CliXdish™
Version or Model: 693006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 693006
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026930061
Issuing Agency: HIBCC
Commercial Distribution End Date: June 01, 2024
Device Count: 5
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: CliXdish™ Mixing Well Refill

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
45119	Dappen dish, reusable	A small, shallow, hand-held concave vessel made of glass or metal used to mix dental materials chairside prior to application to the patient during dental procedures. The user dispenses the required amount of component materials into the device and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
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: Yes 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: Keep away from direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 CliXdishes

Device Record Status

Public Device Record Key: 7c7ec0cd-f2a0-4efc-8d9a-44df59c15785
Public Version Date: June 03, 2024
Public Version Number: 2
DI Record Publish Date: August 16, 2022