FDA Registration
Active
🇰🇷 South Korea
SH07LA2
Reg #: 3006223010
·
FEI: 3006223010
·
Expires 2025
Products
1
Proprietary Names
563
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENOSS Co., Ltd.
- Registration Number
- 3006223010
- FEI Number
- 3006223010
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1201-1207, Gwanggyo business Center, 156, Gwanggyo-ro,, Yeongtong-gu,
- City
- Suwon-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K160079
Owner / Operator
- Firm Name
- GENOSS Co., Ltd.
- Operator Number
- 10023093
- Address
- 12F, 76, Changnyong-daero 256beon-gil,, Yeongtong-gu
- City
- Suwon-si
- State
- Gyeonggi
- Postal Code
- 16229
- Country
- KR
- Correspondent
- Sung Min Chung
US Agent
- Business Name
- DENTIUM USA
- Contact Name
- EUNKYUNG SON
- Address
- 6731 KATELLA AVE
- City
- Cypress
- State
- CA
- ZIP
- 90630
- Country
- US
- [email protected]
- Phone
- 714 2260229
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-11-22 |
Proprietary Names
SH07LA2
SH9828A0
SH6525CA1
SH9510ZA4
SH9510ZA1
SH0020A4
SH9825WA4
SH9825WA2
SH03LA2
SH9814A0
SH4015CA1
SH4015CA3
SH9522A0
SH0025A3
SH0010A0
SH9822WA0
SH9826A3
SH0020A05
SH8720A0
SH8720A3
SH9826WA2
SH0024A3
SH9822WA4
SH9822A2
SH8718A3
SH09A0
SH8724A4
SH9828WA1
SH09LA2
SH09LA3
SH9522A3
SH9522ZA4
SH9522ZA1
SH9810WA3
SH8722A3
SH9526ZA2
SH6525CA05
SH05LA05
SH9520ZA05
SH0018A1
SH9824A05
SH9512A4
SH9526A2
SH03A1
SH0012A1
SH8724A2
SH9510ZA3
SH9510ZA0
SH5519CA2
SH0022A1
SH9514ZA1
SH05A4
SH5519CaA05*
SH9516A05
SH9814WA2
SH07A1
SH07HA05
SH9818A05
SH9514A2
SH9524ZA3
SH9522A2
SH9522ZA2
SH0028A4
SH9810WA1
SH8726A0
SH0018A4
SH9526A3
SH12A4
SH8720A05
SH9510ZA2
SH9825WA1
SH9514ZA4
SH0014A0
SH9526ZA05
SH9818A4
SH12LA05
SH03A05
SH9526ZA1
SH9518ZA4
SH9524A2
SH9816WA3
SH8726A4
SH8726A3
SH9822A3
SH09A05
SH12A1
SH9828WA05
SH9525ZA0
SH9825WA0
SH09HA2
SH2019CA1
SH05HA3
SH9528ZA1
SH9528ZA2
SH9826A4
SH8714A4
SH9518A3
SH07LA4
SH9828A1
SH4019CA0
SH9514A0
SH9820A1
SH01HA05
SH05HA05
SH0022A4
SH2019CA0
SH0024A05
SH9528ZA3
SH9822WA1
SH9814WA0
SH9820WA0
SH8720A2
SH9824A1
SH5519CaA0*
SH9828A2
SH0012A4
SH8714A05
SH8728A05
SH12HA1
SH5519CA0
SH9814A1
SH9522ZA3
SH9522A1
SH9810WA4
SH0016A1
SH9524A1
SH07A2
SH8720A4
SH16HA1
SH9818WA2
SH9820A0
SH9820A2
SH05A3
SH9510A3
SH8725A1
SH9812WA0
SH9526ZA3
SH9518ZA1
SH07HA4
SH0026A3
SH9526A4
SH6525CA2
SH8718A2
SH03LA05
SH9516ZA3
SH9525A3
SH9525A0
SH9820A4
SH4015CA05
SH9818A2
SH9818A3
SH01A05
SH0010A3
SH9820WA3
SH16A4
SH9820A05
SH9824A4
SH9516ZA05
SH12HA2
SH9520A05
SH9820A3
SH0022A0
SH05HA4
SH8722A2
SH9516A1
SH9812A05
SH9518ZA2
SH9816A0
SH8712A3
SH9818WA4
SH8724A05
SH9512ZA4
SH8724A3
SH9525ZA1
SH9520A3
SH9520ZA1
SH0012A2
SH9825WA05
SH09LA4
SH9820WA05
SH9524ZA1
SH9514A05
SH8716A2
SH9514ZA05
SH9822A0
SH0016A05
SH2019CA2
SH09HA0
SH12HA3
SH0028A1
SH9528A4
SH9814A2
SH16LA2
SH16LA4
SH0014A1
SH9516A4
SH9812WA2
SH9528ZA4
SH05HA1
SH0010A4
SH0012A05
SH8728A1
SH8728A3
SH5519CaA2*
SH9518ZA0
SH9514ZA0
SH2019CA4
SH9825A1
SH9520ZA3
SH9812A0
SH9824WA05
SH9818A0
SH0016A2
SH9812A2
SH16A05
SH9514A1
SH05A2
SH8714A3
SH09LA1
SH8718A1
SH01LA0
SH9810A4
SH9826A0
SH2015CA0
SH9518A4
SH0024A0
SH03HA4
SH01A2
SH9814A4
SH12LA2
SH0028A2
SH9512A2
SH9512A1
SH9526A0
SH0014A3
SH9516A3
SH9516A0
SH9514A4
SH9514A3
SH09A2
SH07HA2
SH01HA4
SH8718A4
SH09HA4
SH9828A05
SH0012A3
SH03A3
SH8714A1
SH16A1
SH981605
SH9525ZA2
SH9525ZA4
SH8726A1
SH03LA0
SH2015CA3
SH9525A4
SH9520ZA2
SH9525ZA05
SH9510A4
SH8725A2
SH9518A0
SH9524A4
SH16A0
SH8712A05
SH9814WA4
SH12A05
SH8726A2
SH9512A0
SH9824WA2
SH9814A05
SH8714A0
SH9816WA0
SH0024A2
SH16A3
SH03HA0
SH12LA0
SH9816A3
SH16HA0
SH9824WA1
SH16HA3
SH0026A1
SH0028A05
SH9822A4
SH03A0
SH9514ZA2
SH0010A2
SH0010A1
SH8722A0
SH9512ZA0
SH9814WA1
SH9525A05
SH07LA0
SH4019CA4
SH8724A1
SH9525ZA3
SH9826A05
SH8712A0
SH16HA2
SH9525A2
SH0018A05
SH4015CA2
SH05LA4
SH9520ZA4
SH6525CA4
SH8722A4
SH9512ZA3
SH9826A1
SH12A0
SH9518ZA3
SH4019CA3
SH16A2
SH8720A1
SH0026A0
SH03LA1
SH0024A4
SH12A2
SH03A2
SH8710A1
SH0018A0
SH8726A05
SH05LA1
SH8718A0
SH9828WA4
SH8712A2
SH9824WA0
SH9526A1
SH9812WA1
SH9528A0
SH6525CA3
SH07LA3
SH12HA4
SH0014A4
SH9810WA2
SH01LA4
SH8724A0
SH0020A0
SH16LA1
SH07LA05
SH8725A4
SH0014A05
SH09LA05
SH0024A1
SH8725A0
SH9524ZA4
SH12HA05
SH9524A05
SH9526ZA0
SH9816WA05
SH9528A1
SH0022A3
SH5519CaA4*
SH07A3
SH9826WA3
SH9816WA4
SH9522ZA0
SH9812WA3
SH9818WA3
SH9512ZA05
SH9824WA3
SH03HA1
SH01A0
SH9825A0
SH9825A4
SH9828WA0
SH9828WA3
SH8716A05
SH09LA0
SH9516ZA2
SH2015CA2
SH0020A1
SH0020A3
SH8716A4
SH8716A0
SH9525A1
SH8710A2
SH0028A3
SH8710A4
SH2019CA05
SH07LA1
SH4019CA2
SH4019CA1
SH0026A05
SH03A4
SH9514ZA3
SH2019CA3
SH05LA0
SH0014A2
SH9818A1
SH05HA0
SH8725A3
SH9516ZA1
SH9826A2
SH8716A1
SH9524ZA2
SH8710A0
SH05LA3
SH07HA1
SH9826WA0
SH12LA4
SH9818WA05
SH9820WA1
SH0018A2
SH9524ZA05
SH01HA3
SH9816A1
SH03HA2
SH8712A4
SH9518A1
SH8718A05
SH9518A2
SH9510A1
SH01A3
SH01LA3
SH07HA0
SH01A1
SH9822A1
SH9520A4
SH9520ZA0
SH9828A4
SH8722A05
SH9522ZA05
SH01LA05
SH9810WA0
SH9518A05
SH9516A2
SH9822WA3
SH01LA2
SH9524A0
SH9810A2
SH9826WA1
SH9826WA4
SH12LA1
SH0010A05
SH16HA4
SH0026A2
SH6525CA0
SH09A4
SH9524ZA0
SH8716A3
SH9825WA3
SH0022A2
SH16LA05
SH0016A0
SH05A0
SH07HA3
SH9822A05
SH9816A2
SH9824A2
SH9824A3
SH9825A3
SH12A3
SH09A3
SH03LA4
SH05A05
SH09HA1
SH9528A3
SH4015CA4
SH0016A4
SH8728A4
SH5519CA05
SH9822WA05
SH8714A2
SH9816A4
SH9828WA2
SH9516ZA0
SH5519CA3
SH9528A2
SH9510ZA05
SH4019CA05
SH9812WA4
SH9810A05
SH8728A0
SH9820WA4
SH9812A3
SH07A0
SH9810A0
SH0018A3
SH12LA3
SH9824WA4
SH9814WA05
SH09A1
SH12HA0
SH8710A05
SH05HA2
SH5519CaA1*
SH9812A1
SH01HA1
SH9810A1
SH03HA3
SH9825A2
SH9512ZA2
SH9512ZA1
SH0012A0
SH9516ZA4
SH9522A05
SH09HA3
SH05LA2
SH8725A05
SH07A05
SH0028A0
SH8728A2
SH9510A05
SH16HA05
SH9826WA05
SH9810A3
SH9810WA05
SH2015CA4
SH5519CaA3*
SH5519CA4
SH8710A3
SH8712A1
SH9818WA1
SH0025A1
SH4015CA0
SH0025A4
SH9812A4
SH01HA0
SH03HA05
SH9528A05
SH9520A2
SH9520A1
SH0020A2
SH9522A4
SH5519CA1
SH0022A05
SH9518ZA05
SH0025A2
SH9526A05
SH16LA0
SH0016A3
SH9510A2
SH9822WA2
SH9524A3
SH9820WA2
SH01HA2
SH9512A3
SH9818WA0
SH9520A0
SH9828A3
SH9812WA05
SH2015CA1
SH03LA3
SH9512A05
SH0025A0
SH09HA05
SH16LA3
SH8722A1
SH01LA1
SH9526ZA4
SH9825A05
SH07A4
SH9816WA1
SH9816WA2
SH0025A05
SH9824A0
SH0026A4
SH2015CA05
SH9814A3
SH9510A0
SH9528ZA0
SH05A1
SH9814WA3
SH01A4
Establishment Types
Manufacture Medical Device