REGEN Bioactive Cement
FDA 510(k) K253337 · Inter-Med, Inc.
510(k) numberK253337
Submission
- Device name
- REGEN Bioactive Cement
- Applicant
- Inter-Med, Inc.
Racine, WI, US - Received
- September 30, 2025
- Decision date
- April 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250953 | Equia LC OneEMA · Traditional | GC America, Inc. | 09/19/2025SE |
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| K871291 | Am Cath Eswl StentFAD · Traditional | 04/30/1987SE |
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Questions and answers
When was REGEN Bioactive Cement cleared by the FDA?
REGEN Bioactive Cement (K253337) received a 510(k) decision of Substantially Equivalent on April 15, 2026, 197 days after the submission was received.
What is the product code of K253337?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.