FDA.reportPublic FDA data

Flight Dental Systems

Primary DI
D178CLAVE28
Brand
Flight Dental Systems
Company
Flight Dental Systems USA Inc.
Model
Clave28+
Catalog number
Clave28+
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.
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243994000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243994000Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.2025-06-06FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D178CLAVE28PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
346-398-4817info@flightdentalsystems.com

Regulatory Flags#

DUNS number
119439759
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D178A12H0Flight Dental SystemsA12HA12H2025-08-29
D178A12HP1000Flight Dental SystemsA12H-100A12 Operatory Package2025-08-29
D178A6E0Flight Dental SystemsA6E2025-08-29
D178A6EP1000Flight Dental SystemsA6EP-1002025-08-29
D178A6EP10120Flight Dental SystemsA6EP-1022025-08-29
D178BI22530K1Flight Dental SystemsBI-2530K2025-08-29
D178F160Flight Dental SystemsF-1602025-08-29
D178FMS25300Flight Dental SystemsFMS-25302025-08-29
D178N6LED19020Flight Dental SystemsN6LED-19022025-08-29
D178QC164K1Flight Dental SystemsQC-164K2025-08-29
D178QC165K1Flight Dental SystemsQC-165K2025-08-29
D178QC170Flight Dental SystemsQC-170KQC-170K2025-08-29
D178XR3800Flight Dental SystemsXR-3800X-Vision2025-08-29
D178CLAVE16Flight Dental SystemsClave16+Clave16+2025-07-18
D178CLAVE23Flight Dental SystemsClave23+Clave23+2025-07-18
D178CLAVE45Flight Dental SystemsClave45+Clave45+2025-07-18
D178CLAVE8Flight Dental SystemsClave8+Clave8+2025-07-18

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Primary DI, Brand, Company table
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05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
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