FDA.report

510(k) K231411

Device
INNO SLA Submerged Hybrid Ti-Base System
Applicant
Cowellmedi Co., Ltd.
510(k) number
K231411
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-20
Date received
2023-05-16
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Haejun Lee
Address
48, Hakgam-Daero 221beon-Gil, Sasang-Gu Busan KR 46986 46986

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08800016106183INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016108590INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016108576INNO SLA Submerged Hybrid Ti-Base System-Hybrid A Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016108491INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016108484INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106398INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106381INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106374INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106367INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106336INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106237INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106220INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016108606INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106176INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106169INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106152INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106145INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106138INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106121INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016106091INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016103144INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016103137INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016103120INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115628INNO SLA Submerged Hybrid Ti-Base System-Hybrid S Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115734INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115727INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115710INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115703INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115697INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24
08800016115680INNO SLA Submerged Hybrid Ti-Base System-Hybrid L Ti-BaseCowellmedi Co.,Ltd2024-05-24

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