FDA.report

510(k) K231395

Device
INNO SLA Submerged Narrow Implant System
Applicant
Cowellmedi Co., Ltd.
510(k) number
K231395
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-18
Date received
2023-05-15
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

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
08809471729821INNO SLA Submerged Narrow Implant System-No-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08809471729869INNO SLA Submerged Narrow Implant System-Cover ScrewCowellmedi Co.,Ltd2024-05-24
08809471729876INNO SLA Submerged Narrow Implant System-Cover ScrewCowellmedi Co.,Ltd2024-05-24
08809471729883INNO SLA Submerged Narrow Implant System-Cover ScrewCowellmedi Co.,Ltd2024-05-24
08809471729890INNO SLA Submerged Narrow Implant System-Healing Abutment - Type1Cowellmedi Co.,Ltd2024-05-24
08809471729906INNO SLA Submerged Narrow Implant System-Healing Abutment - Type1Cowellmedi Co.,Ltd2024-05-24
08809471729913INNO SLA Submerged Narrow Implant System-Healing Abutment - Type1Cowellmedi Co.,Ltd2024-05-24
08809471729920INNO SLA Submerged Narrow Implant System-Healing Abutment - Type1Cowellmedi Co.,Ltd2024-05-24
08809471729937INNO SLA Submerged Narrow Implant System-Healing Abutment - Type1Cowellmedi Co.,Ltd2024-05-24
08809471729944INNO SLA Submerged Narrow Implant System-Straight AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729951INNO SLA Submerged Narrow Implant System-Straight AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729968INNO SLA Submerged Narrow Implant System-Straight AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729975INNO SLA Submerged Narrow Implant System-Straight AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729982INNO SLA Submerged Narrow Implant System-Straight AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729845INNO SLA Submerged Narrow Implant System-No-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08809471729838INNO SLA Submerged Narrow Implant System-No-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08809471729807INNO SLA Submerged Narrow Implant System-Pre-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08809471729784INNO SLA Submerged Narrow Implant System-Pre-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08800016161151INNO SLA Submerged Narrow Implant System-Multi S AbutmentCowellmedi Co.,Ltd2024-05-24
08800016112573INNO SLA Submerged Narrow Implant System-Multi A Abutment (Non-hex Type)Cowellmedi Co.,Ltd2024-05-24
08800016100402INNO SLA Submerged Narrow Implant System-Multi S AbutmentCowellmedi Co.,Ltd2024-05-24
08800016161144INNO SLA Submerged Narrow Implant System-Multi S AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729814INNO SLA Submerged Narrow Implant System-No-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08800016161427INNO SLA Submerged Narrow Implant System-Abutment ScrewsCowellmedi Co.,Ltd2024-05-24
08800016161168INNO SLA Submerged Narrow Implant System-Multi S AbutmentCowellmedi Co.,Ltd2024-05-24
08809471729791INNO SLA Submerged Narrow Implant System-Pre-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08800016112580INNO SLA Submerged Narrow Implant System-Multi A Abutment (Non-hex Type)Cowellmedi Co.,Ltd2024-05-24
08800016112566INNO SLA Submerged Narrow Implant System-Multi A Abutment (Non-hex Type)Cowellmedi Co.,Ltd2024-05-24
08809471729777INNO SLA Submerged Narrow Implant System-Pre-Mount Type FixtureCowellmedi Co.,Ltd2024-05-24
08800016161410INNO SLA Submerged Narrow Implant System-Abutment ScrewsCowellmedi Co.,Ltd2024-05-24

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