FDA.report

510(k) K214086

Device
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
Applicant
Genoss Co., Ltd.
510(k) number
K214086
Product code
ELW
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-15
Date received
2021-12-27
Regulation
872.3660
Classification name
Material, Impression
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
Woojung Park
Address
1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro, Yeongtong-Gu, Suwon-Si KR 16229 16229

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code ELW

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K254112Dia-X Sil BiteDiaDent Group International2026-03-19
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K241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.2024-12-27
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K223892DentMix VPS Impression MaterialInnovative Product Brands, Inc.2023-04-27
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K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)Hdi, Inc.2022-11-07
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K221668Dental Impression MaterialChemoment Materials Co.,Ltd2022-08-08
K213890IMICRYL Impression MaterialsImicryl Dis Malzemeleri San. VE Tic. A.S.2022-02-11
K220257Permadyne3M Deutschland GmbH2022-02-01
K220097PRESIDENT The OriginalColtène/Whaledent AG2022-01-13
K211489Dental Impression MaterialNanchang Dental Bright Technology Co., Ltd.2021-07-28