The Slide
FDA 510(k) K203712 · Biotex, Inc.
510(k) numberK203712
Submission
- Device name
- The Slide
- Applicant
- Biotex, Inc.
Houston, TX, US - Received
- December 21, 2020
- Decision date
- July 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was The Slide cleared by the FDA?
The Slide (K203712) received a 510(k) decision of Substantially Equivalent on July 20, 2021, 211 days after the submission was received.
What is the product code of K203712?
The FDA product code is LQZ – Device, Jaw Repositioning, a Class II (moderate risk) device regulated under 21 CFR 872.5570.