StarDental Instrument Solutions

Basic Information

• Brand Name: StarDental Instrument Solutions
• Primary DI: D702RT3001130
• Version / Model: RT3-00113
• Company Name: DENTALEZ, INC.
• Labeler DUNS: 059010363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: c2b182a3-0361-4635-bdc4-049f3b4e3b73

Device Description

Patient Glasses (Yellow)

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	886.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46297	Tinted non-prescription spectacle lens	An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D702RT3001130	HIBCC

Customer Contacts

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