Flight Dental Systems

Basic Information

• Brand Name: Flight Dental Systems
• Primary DI: D178CLAVE45
• Version / Model: Clave45+
• Catalog Number: Clave45+
• Company Name: Flight Dental Systems USA Inc.
• Labeler DUNS: 119439759
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-18
• Public Version: 1
• Public Version Date: 2025-07-28
• Public Version Status: New
• Public Device Record Key: e4854e17-e013-43b7-9549-e0b147d227c3

Device Description

Clave45+ Steam Sterilizer – Large Capacity with Class B Upgradability The Clave45+ from Flight Dental Systems is a versatile and high-capacity steam sterilizer designed to meet the evolving needs of growing dental and medical practices. With a generous 45-liter chamber, this unit is ideal for clinics handling larger instrument loads or surgical setups. It comes standard as a Class S sterilizer, with the option to upgrade to Class B, giving users flexibility and future-proofing their investment.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FLE	Sterilizer, Steam	General Hospital	880.6880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38671	Steam sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D178CLAVE45	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K243994	000