ROBOT POINTS PRO-CUT

Basic Information

• Brand Name: ROBOT POINTS PRO-CUT
• Primary DI: 04548162335487
• Version / Model: D010EF
• Catalog Number: D010EF
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-09-04
• Public Version: 1
• Public Version Date: 2024-09-12
• Public Version Status: New
• Public Device Record Key: 46fcc0c0-26af-422f-ba8b-4f7546e7df7d

Device Description

ROBOT POINTS PRO-CUT FG D010EF 5pcs

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: Yes
• Has Expiration Date: Yes
• 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
DZP	INSTRUMENT, DIAMOND, DENTAL	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16670	Diamond dental bur, reusable	A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14548162335484	GS1	Box	10	In Commercial Distribution
Primary	04548162335487	GS1
Unit of Use	84548162335483	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius