Compo-Dots Composite Condensing Dots Angle

Basic Information

• Brand Name: Compo-Dots Composite Condensing Dots Angle
• Primary DI: 00723896006214
• Version / Model: 71-05714
• Catalog Number: 71-05714
• Company Name: PRACTICON, INC.
• Labeler DUNS: 119193803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2019-06-17
• Public Version: 1
• Public Version Date: 2019-06-25
• Public Version Status: New
• Public Device Record Key: 8491a889-e67a-436d-b1e4-c01d0c6eaff7

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00723896006214	GS1
Unit of Use	00723896006207	GS1