Samsung 10DR Implant System
FDA 510(k) K002062 · Samsung Sds Co., Ltd.
510(k) numberK002062
Submission
- Device name
- Samsung 10DR Implant System
- Applicant
- Samsung Sds Co., Ltd.
Aubrey, TX, US - Received
- July 6, 2000
- Decision date
- November 9, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Samsung 10DR Implant System cleared by the FDA?
Samsung 10DR Implant System (K002062) received a 510(k) decision of Substantially Equivalent on November 9, 2000, 126 days after the submission was received.
What is the product code of K002062?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.