FDA.reportPublic FDA data

BRAVO G4 Chamber Autoclave

Primary DI
07640397422318
Brand
BRAVO G4 Chamber Autoclave
Company
Dent4You AG
Model
7A621030-L
Catalog number
7A621030-L
Device description
Dynamic-air-removal (pre-vacuum) table-top steam sterilizer, 22L, 240V (Loaner)
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K210326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210326000Bravo G4 Chamber AutoclaveScican , Ltd.2021-07-01FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640397422318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640397422318076403974223187640397422318

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.

Regulatory Flags#

DUNS number
480152811
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397420390HIP Ultra Cleaning SolutionCS-HIPC-UCS-HIPC-U2026-05-06
07640397420406HIP Cleaning SolutionCS-HIPLCS-HIPL2026-05-06
07640397422332HIP Cleaning SolutionCS-HIPTCS-HIPT2026-02-11
07630243627981BRILLIANT EverGlow60019697600196972026-04-28
07630243627998BRILLIANT EverGlow60019698600196982026-04-28
07630243628001BRILLIANT EverGlow60019699600196992026-04-28
07630243628018BRILLIANT EverGlow60019700600197002026-04-28
07630243628025BRILLIANT EverGlow60019701600197012026-04-28
07630243628032BRILLIANT EverGlow60019702600197022026-04-28
07630243628049BRILLIANT EverGlow60019703600197032026-04-28
07630243628056BRILLIANT EverGlow60019704600197042026-04-28
07630243628063BRILLIANT EverGlow60019705600197052026-04-28
07630243628070BRILLIANT EverGlow60019706600197062026-04-28
07630243628087BRILLIANT EverGlow60019707600197072026-04-28
07630243628094BRILLIANT EverGlow60019708600197082026-04-28
07630243628100BRILLIANT EverGlow60019709600197092026-04-28
07630243628117BRILLIANT EverGlow60019710600197102026-04-28
07630243628124BRILLIANT EverGlow60019716600197162026-04-28
07630243628131BRILLIANT EverGlow60019717600197172026-04-28
07630243628148BRILLIANT EverGlow60019718600197182026-04-28

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Primary DI, Brand, Company table
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06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26
07640397422271BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422288BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422295BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
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07640397421748STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664303EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664310EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548835Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548873Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533549023Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
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