FDA.reportPublic FDA data

EZ SHOT SE

Primary DI
08800025400692
Brand
EZ SHOT SE
Company
GOOD DOCTORS CO., LTD.
Model
IC-EZSE10
Device description
Intraoral Camera
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025400692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025400692088000254006928800025400692

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688201036
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800025400159Dr.s cam VIC-DCCU742020-01-16
08800025400173EZ SHOT HD VIC-EZBU822020-01-16
08800025400456Dr's Light PRIMECL-DP402023-08-24
08800025400463Dr's Light CHOICECL-DP402023-08-24
08800025400524File Hook(1pcs)AC04012023-08-23
08800025400531Lip Hook(3pccs)AC04072023-08-23
08800025400135InspireIC-WHCD1002020-11-13
18800025400156Dr.s cam VIC-DCCU742020-01-16
18800025400170EZ SHOT HD VIC-EZBU822020-01-16
08800025400296Charger_DLDLT030M20012019-11-26
08800025400203Charger_Drs Light ClaverDC020M10012019-11-22
08800025400210Battery_Drs Light ClaverCL02001102019-11-22
08800025400227Guide-cap_Drs Light ClaverCL02002102019-11-22
08800025400234Disposable cover_35x100_wideIC06002202019-11-22
08800025400241Disposable cover_60x200_wideIC06002302019-11-22
08800025400258Disposable cover_35x100_narrowIC06002102019-11-22
08800025400265Disposable cover_46x195_wide/100 pcsIC06002302019-11-22
08800025400289Disposable cover_60x280_narrowIC06002502019-11-22
08800025400012Whicam Story3_wirelessIC-WHT602019-10-30
08800025400029Whicam Story3_wiredIC-WHW612019-10-30

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Primary DI, Brand, Company table
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05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2026-05-15
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15