Flight Dental Systems

Basic Information

• Brand Name: Flight Dental Systems
• Primary DI: D178CLAVE28
• Version / Model: Clave28+
• Catalog Number: Clave28+
• 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: 42011795-48cf-443e-9d5b-d4cddde54a48

Device Description

The Clave28+ from Flight Dental Systems is a high-capacity Class S steam sterilizer designed to meet the sterilization needs of busy dental and medical practices. With a spacious 28-liter chamber, the Clave28+ offers efficient and reliable sterilization for solid, unwrapped instruments and other general-use items, making it ideal for clinics that require fast turnaround and dependable performance.

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	D178CLAVE28	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243994	000