FDA.reportPublic FDA data

BESDATA

Primary DI
06971355352608
Brand
BESDATA
Company
Shenzhen BesdataTechnology Co., LTD.
Model
OT-BR002
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
16971355350533PackageGS110In Commercial Distribution
06971355352608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697135535053316971355350533
06971355352608069713553526086971355352608

GMDN Terms#

Term, Definition table
TermDefinition
Video otoscope/audiometerAn electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch generator (speaker), and a dedicated smartphone for image display and data relay to a central datastore; it may provide a conduit for a microsuction device.

Regulatory Flags#

DUNS number
418821086
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971355350147BESDATAMil02026-09-04
06971355350154BESDATAMac12026-09-04
06971355350161BESDATAMac32026-09-04
06971355350178BESDATAMac42026-09-04
06971355350512BESDATAD-blade2026-09-04
06971355350529BESDATAMil12026-09-04
06971355350888BESDATAMac22026-09-04
06971355352592BESDATAOT-BR0012026-09-04
06971355352615BESDATAOT-BR0032026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971355352592BESDATAShenzhen BesdataTechnology Co., LTD.QJK2026-09-04
06971355352615BESDATAShenzhen BesdataTechnology Co., LTD.QJK2026-09-04
07899581345197Intraoral ScannerAlliage S/A Indústrias Médico OdontológicaQJK2026-08-22
07899581360671Intraoral ScannerAlliage S/A Indústrias Médico OdontológicaQJK2026-08-22
00816063022312iTero Lumina Pro DOAAlign Technology, Inc.QJK2026-06-25
06971119542399Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
06971119542405Intra Oral CameraGuangdong JINME Medical Technology Co., Ltd.QJK2025-09-18
06971119540968Intra Oral ScannerGuangdong JINME Medical Technology Co., Ltd.QJK2025-07-15
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