Dental Instrument

Basic Information

• Brand Name: Dental Instrument
• Primary DI: 08800016161519
• Version / Model: KSALT030
• Company Name: Cowellmedi Co.,Ltd
• Labeler DUNS: 688753763
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-08
• Public Version: 2
• Public Version Date: 2025-10-15
• Public Version Status: Update
• Public Device Record Key: d9252c7e-f8be-451f-a707-7b7b17ce4b66
• Distribution End Date: 2025-10-14

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: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64314	Dental elevator, sinus lift	A hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800016161519	GS1