AccessGUDID - DEVICE: Compo-Dots Composite Condensing Dots Small (00723896010693)

GUDID

Device Identifier (DI) Information

Brand Name: Compo-Dots Composite Condensing Dots Small
Version or Model: .2188DIAx3/16"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-05710
Company Name: PRACTICON, INC.

Primary DI Number: 00723896010693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Rid your composite restorations of voids and open margins!Compo-Dots Composite Condensing Dots are tiny, non-stick foam sponges perfectly sized to condense composites into Class I, II and III preps. Elastic memory provides an ideal compressive force and prevents "draw-back" of composite materials upon removal. 100 disposable blue dots per bag. Small Compo-Dots are best for Class II and III preps.

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:	Yes
Prescription Use (Rx):	No
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?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a0dfdb1-cf46-479e-a426-c0366f39f114
Public Version Date: November 08, 2018
Public Version Number: 2
DI Record Publish Date: July 19, 2018