Internal Octa Implant System
FDA 510(k) K170031 · Ebi, Inc.
510(k) numberK170031
Submission
- Device name
- Internal Octa Implant System
- Applicant
- Ebi, Inc.
Gyeongsan-Si, KR - Received
- January 4, 2017
- Decision date
- August 31, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Internal Octa Implant System cleared by the FDA?
Internal Octa Implant System (K170031) received a 510(k) decision of Substantially Equivalent on August 31, 2017, 239 days after the submission was received.
What is the product code of K170031?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.