Tetric plus Fill;Tetric plus Flow
FDA 510(k) K261485 · Ivoclar Vivadent, Inc.
510(k) numberK261485
Submission
- Device name
- Tetric plus Fill;Tetric plus Flow
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- May 5, 2026
- Decision date
- July 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Tetric plus Fill;Tetric plus Flow cleared by the FDA?
Tetric plus Fill;Tetric plus Flow (K261485) received a 510(k) decision of Substantially Equivalent on July 1, 2026, 57 days after the submission was received.
What is the product code of K261485?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.