Waterpik Densco Condensaire Amalgam Condenser

Basic Information

• Brand Name: Waterpik Densco Condensaire Amalgam Condenser
• Primary DI: D6860831110003
• Version / Model: 083111-000
• Catalog Number: 083111-000
• Company Name: WATER PIK, INC.
• Labeler DUNS: 001804074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: 78000d21-bc55-4192-87a1-50b19052f68b

Device Description

Instrument only

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKG	Condenser, Amalgam And Foil, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16460	Dental amalgam condenser, reusable	A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D6860831110003	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]