FDA.reportPublic FDA data

Osstem Implant Co.,Ltd.

Primary DI
08800000995656
Brand
Osstem Implant Co.,Ltd.
Company
Osstem Implant Co.,Ltd.
Model
SNAP Wired
Device description
The intraoral camera with a B applied Part is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures. It can be connected to a USB hub that is connected to be directly connected to a Laptop or Desktop computer USB ports.
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08800000995656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000995656088000009956568800000995656

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.

Regulatory Flags#

DUNS number
696467699
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
false
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
08800040673866HySil Impression Materials (Heavy, Mono, and Bite)ESS380H2020-11-17
08800040673873HySil Impression Materials (Heavy, Mono, and Bite)ESS380M2020-11-17
08800040673880HySil Impression MaterialsESS400P2020-11-17
08800040673897HySil Impression Materials (Heavy, Mono, and Bite)ESS50B2020-11-17
08800040673903HySil Impression MaterialsESS50EL2020-11-17
08800040673910HySil Impression MaterialsESS50HB2020-11-17
08800040673927HySil Super Fast Impression MaterialsESS50HF2020-11-17
08800040673934HySil Super Fast Impression MaterialsESS50HFB2020-11-17
08800040673941HySil Super Fast Impression MaterialsESS50HFD2020-11-17
08800040673958HySil Impression MaterialsESS50H2020-11-17
08800040673965HySil Impression MaterialsESS50LB2020-11-17
08800040673972HySil Super Fast Impression MaterialsESS50LF2020-11-17
08800040673989HySil Super Fast Impression MaterialsESS50LFB2020-11-17
08800040673996HySil Super Fast Impression MaterialsESS50LFD2020-11-17
08800040674009HySil Impression MaterialsESS50L2020-11-17
08800040674016HySil Impression MaterialsESS50MB2020-11-17
08800040674023HySil Super Fast Impression MaterialsESS50MF2020-11-17
08800040674030HySil Super Fast Impression MaterialsESS50MFB2020-11-17
08800040674047HySil Super Fast Impression MaterialsESS50MFD2020-11-17
08800040674054HySil Impression MaterialsESS50M2020-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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