FDA.reportPublic FDA data

Intra Oral Scanner

Primary DI
06971119540968
Brand
Intra Oral Scanner
Company
Guangdong JINME Medical Technology Co., Ltd.
Model
ECO-SCANNER 1
Device description
Intra Oral Scanner
Published
2025-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QJKIntraoral Camera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJKIntraoral CameraDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971119540968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971119540968069711195409686971119540968

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
543260808
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971119541323Dental chair and accessoriesS6102026-03-30
06971119541316Dental chair and accessoriesS6902025-07-15
06971119540975Intra Oral ScannerECO-SCANNER 22025-07-15
06971119542399Intra Oral CameraECO-CAMERA 012025-09-18
06971119542405Intra Oral CameraECO-CAMERA 022025-09-18
06971119541897Air compressor Air compressor2025-07-23
06971119541903Testing machineHP Tester2025-07-23
06971119540036Dental Low-Speed Turbine Handpiece LN2025-07-15
06971119540135Dental High-Speed Turbine Handpiece SUQP2025-07-15
06971119540142Dental High-Speed Turbine Handpiece TUQP2025-07-15
06971119540159Dental High-Speed Turbine Handpiece SUQ2025-07-15
06971119540166Dental High-Speed Turbine Handpiece TUQ2025-07-15
06971119540173Dental High-Speed Turbine Handpiece SUP2025-07-15
06971119540180Dental High-Speed Turbine Handpiece TUP2025-07-15
06971119540197Dental High-Speed Turbine Handpiece SP2025-07-15
06971119540203Dental High-Speed Turbine Handpiece TP2025-07-15
06971119540227Dental High-Speed Turbine Handpiece SU2025-07-15
06971119540234Dental High-Speed Turbine Handpiece TU2025-07-15
06971119540258Dental High-Speed Turbine Handpiece S2025-07-15
06971119540265Dental High-Speed Turbine Handpiece T2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971119542399Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
06971119542405Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
06971119540975Intra Oral ScannerGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
06971119542382Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
00816063023067iTero Lumina ProAlign Technology, Inc.QJK2025-03-06
00816063022213iTero Lumina ProAlign Technology, Inc.QJK2024-11-19
00816063022237iTero Lumina Pro MobileAlign Technology, Inc.QJK2024-11-19
00816063022268iTero Lumina Pro intraoral scanning unitAlign Technology, Inc.QJK2024-11-19
00816063022329iTero Lumina Pro DOAAlign Technology, Inc.QJK2024-11-19
00816063022428iTero Lumina Pro UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022442iTero Lumina Pro Mobile UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022466iTero Lumina Pro UpgradeAlign Technology, Inc.QJK2024-11-19
00816063022589iTero Lumina Pro Wand Barrier SleevesAlign Technology, Inc.QJK2024-11-19
00816063022657iTero Lumina ProAlign Technology, Inc.QJK2024-11-19
00816063022664iTero Lumina ProAlign Technology, Inc.QJK2024-11-19
08800000995649Osstem Implant Co.,Ltd.Osstem Implant Co.,Ltd.QJK2022-11-30
08800000995656Osstem Implant Co.,Ltd.Osstem Implant Co.,Ltd.QJK2022-11-30