StarDental Instrument Solutions

Basic Information

• Brand Name: StarDental Instrument Solutions
• Primary DI: D7022641520
• Version / Model: 264152
• Company Name: DENTALEZ, INC.
• Labeler DUNS: 059010363
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2020-02-24
• Public Version Status: Update
• Public Device Record Key: f12c763a-c0ca-47e7-862c-68c5b69d40eb
• Distribution End Date: 2019-04-29

Device Description

UNIVERSAL TIP - 100/BAG

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: No
• 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
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44910	Pneumatic dental scaling/debridement system handpiece tip, periodontal, reusable	A removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment and dislodge accretions or substances [e.g., dentine, enamel, plaque, calculus] from tooth and implant surfaces during dental cleaning/periodontal procedures (e.g., stripping, finishing); it is not intended for endodontic use. It is available in a variety of designs and may also be used for the removal of orthodontic cement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7022641520	HIBCC

Customer Contacts

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