hiossen.comK3
OSSTEM IMPLANT CO.,LTD.
OSSTEM IMPLANT CO.,LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3045816948 | 3045816948 | OSSTEM IMPLANT CO.,LTD. | 1 | N | 2026-01-01 | 104 Cheomdan-daero Yeonsu-gu Incheon KR 21989 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08800000995809 | N1 - N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it’s not based on the predicate software. | +1-267-710-6714 | regulatoryaffairs@hiossen.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 350864 | 1261375697 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | EAP | 1995-04-19 |
| 350864 | 1647278569 | K251491 | K5 Cart, K5 Mount, K5 Swing | EIA | 2025-07-17 |
| 350864 | 1857866909 | K233806 | T2 Plus | OAS | 2024-09-06 |
| 350864 | 1616838886 | K233805 | K5 | EIA | 2024-09-03 |
| 350864 | 1024000705 | K232012 | N1 | EHD | 2023-11-28 |
| 350864 | 1155924234 | K212303 | T2 | OAS | 2021-09-21 |
| 350864 | 1116705214 | K183475 | T1-CS, T1-C | OAS | 2019-08-30 |
| 350864 | 1858553116 | K183347 | K3 | EIA | 2019-09-04 |
| 350864 | 1451457261 |
Product Codes Associated With Registrations#
PMN#
US SA Implant System
OSSTEM IMPLANT CO.,LTD.
GUDID#
N1 - N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it’s not based on the predicate software.
2026-08-27
HySil Impression Materials (Heavy, Mono, and Bite) - ESS380H
2020-11-17
HySil Impression Materials (Heavy, Mono, and Bite) - ESS380M
2020-11-17
HySil Impression Materials - ESS400P
2020-11-17
HySil Impression Materials (Heavy, Mono, and Bite) - ESS50B
2020-11-17
HySil Impression Materials - ESS50EL
2020-11-17
HySil Impression Materials - ESS50HB
2020-11-17
HySil Super Fast Impression Materials - ESS50HF
2020-11-17
HySil Super Fast Impression Materials - ESS50HFB
2020-11-17
HySil Super Fast Impression Materials - ESS50HFD
2020-11-17
HySil Impression Materials - ESS50H
2020-11-17
HySil Impression Materials - ESS50LB
2020-11-17
HySil Super Fast Impression Materials - ESS50LF
2020-11-17
HySil Super Fast Impression Materials - ESS50LFB
2020-11-17
HySil Super Fast Impression Materials - ESS50LFD
2020-11-17
HySil Impression Materials - ESS50L
2020-11-17
HySil Impression Materials - ESS50MB
2020-11-17
HySil Super Fast Impression Materials - ESS50MF
2020-11-17
HySil Super Fast Impression Materials - ESS50MFB
2020-11-17
HySil Super Fast Impression Materials - ESS50MFD
2020-11-17
HySil Impression Materials - ESS50M
2020-11-17
Osstem Mixing Tip - OMTH100
2022-12-08
Osstem Mixing Tip - OMTH300
2022-12-08
Osstem Mixing Tip - OMTL100
2022-12-08
Osstem Mixing Tip - OMTL300
2022-12-08
Osstem Mixing Tip - OMTA50
2022-12-08
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS - The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.
2025-09-04
T2 Plus - T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 degree by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.
2025-04-28
T2 Plus - T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 degree by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the X-ray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.
2025-04-28
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS - The K5 is intended to supply power to and serve as a base for dental devices and accessories.This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.
2025-04-24
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS - The K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and suppling water into the oral cavity through a water line in dental clinical environments.
2025-04-24
Estar-ZE - ZEHTA2012M
2024-12-03
Estar-ZE - ZEHTA2014M
2024-12-03
Estar-ZE - ZEHTA2016M
2024-12-03
Estar-ZE - ZEHTA2018M
2024-12-03
Estar-ZE - ZEHTA2020M
2024-12-03
Estar-ZE - ZEHTA2022M
2024-12-03
Estar-ZE - ZEHTA2025M
2024-12-03
Estar-ZE - ZEHTA2030M
2024-12-03
Estar-ZE - ZEHTA3010M
2024-12-03