TKO Composite Bite Turbo Gel
FDA 510(k) K210349 · Reliance Orthodontic Products, Inc.
510(k) numberK210349
Submission
- Device name
- TKO Composite Bite Turbo Gel
- Applicant
- Reliance Orthodontic Products, Inc.
Itasca, IL, US - Received
- February 8, 2021
- 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 TKO Composite Bite Turbo Gel cleared by the FDA?
TKO Composite Bite Turbo Gel (K210349) received a 510(k) decision of Substantially Equivalent on July 20, 2021, 162 days after the submission was received.
What is the product code of K210349?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.