FDA.reportPublic FDA data

IOC-Holder

Primary DI
08800096901043
Brand
IOC-Holder
Company
Dentall co.,Ltd.
Model
IOC-Holder
Device description
Accessories of Intraoral Camera
Published
2020-08-04
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
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
08800096901043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800096901043088000969010438800096901043

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

Contacts#

Phone, Email table
PhoneEmail
+82323276026trade@dentall.co.kr

Regulatory Flags#

DUNS number
690440554
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800096901302EzCamEzCam-Regular kit2020-08-12
08800096901319EzCamEzCam-Handpiece2020-08-12
08800096901326EzCamEzCam-Cable2020-08-12
08800096901333EzCamEzCam-Holder2020-08-12
08800096901012CamstarCamstar-Regular kit2020-08-04
08800096901029CamstarCamstar- handpiece2020-08-04
08800096901036IOC-USB CableIOC-USB Cable2020-08-04
08800096901104LED IC100LED IC100-Regular kit2020-08-04
08800096901111LED IC100LED IC100-Handpiece2020-08-04
08800096901203Opti plus HDOpti plus HD-Regular kit2020-08-04
08800096901210Opti plus HDOpti plus HD-Handpiece2020-08-04
08800096902019B&Lite SB&Lite S-Regular kit2020-08-04
08800096902026B&Lite SB&Lite S-Handpiece2020-08-04
08800096902033B&Lite SB&Lite S-Charger2020-08-04
08800096902040B&Lite SB&Lite S-Battery pack2020-08-04
08800096902057B&Lite SB&Lite S-Light probe2020-08-04
08800096902064B&Lite SB&Lite S-Light Shield2020-08-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
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