AccessGUDID - DEVICE: Compo-Dots Composite Condensing Dots Angle (00723896006214)

GUDID

Device Identifier (DI) Information

Brand Name: Compo-Dots Composite Condensing Dots Angle
Version or Model: 71-05714
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-05714
Company Name: PRACTICON, INC.

Primary DI Number: 00723896006214
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Tiny, non-stick Angle Compo-Dots foam sponges condense composites with no voids or open margins. Elastic memory provides an ideal compressive force and prevents "draw-back" of composite upon removal. Angled end is ideal for interproximal composite surfaces in Class II, III, and IV restorations, while concave end addresses Class V applications at the gumline.

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: 8491a889-e67a-436d-b1e4-c01d0c6eaff7
Public Version Date: June 25, 2019
Public Version Number: 1
DI Record Publish Date: June 17, 2019