Adapter for removable heads

Basic Information

• Brand Name: Adapter for removable heads
• Primary DI: J021026790001
• Version / Model: 02679000
• Company Name: W & H Dentalwerk Bürmoos GmbH
• Labeler DUNS: 300238441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 1
• Public Version Date: 2023-07-19
• Public Version Status: New
• Public Device Record Key: 2095386e-1f83-401e-9798-280668362da8

Device Description

Adapter for Assistina

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
EFB	Handpiece, Air-Powered, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60447	Surgical power tool maintenance adaptor	A device intended to connect a surgical power tool (e.g., pneumatically or electrically driven motors, turbines, or attachments) to a maintenance device (i.e., maintenance unit or lubricant container) during maintenance/lubrication of the surgical power tool. It is typically a metal attachment designed to connect a specific type of tool and maintenance device together.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J021026790001	HIBCC