StarDental Instrument Solutions

Basic Information

• Brand Name: StarDental Instrument Solutions
• Primary DI: D7022020850
• Version / Model: 202085
• Company Name: DENTALEZ, INC.
• Labeler DUNS: 059010363
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-05
• Public Version: 3
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: b10465f6-aad1-4eba-8f10-fcb68e1a050f
• Distribution End Date: 2019-01-07

Device Description

INSTR MG SE EXPLORER 6

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
EKB	Explorer, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7022020850	HIBCC

Customer Contacts

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