StarDental Instrument Solutions

Basic Information

• Brand Name: StarDental Instrument Solutions
• Primary DI: D7022656460
• Version / Model: 265646
• Company Name: DENTALEZ, INC.
• Labeler DUNS: 059010363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-05
• Public Version: 1
• Public Version Date: 2018-12-06
• Public Version Status: New
• Public Device Record Key: 32304082-11fb-4888-8625-5b2a59d382a0

Device Description

LED PLUG 'N PLAY SWIVEL ASSY

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: Yes
• 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
EFB	Handpiece, Air-Powered, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45121	Pneumatic dental handpiece coupler	A short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7022656460	HIBCC

Customer Contacts

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