REGEN Bioactive Cement— 510(k) K253337
Substantially EquivalentInter-Med, Inc.
FDA 510(k) clearance K253337 for REGEN Bioactive Cement, Substantially Equivalent on 2026-04-15. Applicant: Inter-Med, Inc.. Device class: 2.
Summary
Inter-Med's REGEN Bioactive Cement is filed under product code EMA (Cement, Dental). The record doesn't describe the cement beyond its name and that code name.
Class II, 21 CFR 872.3275. It came in as a Traditional 510(k), and Dental is both the classification panel and the review panel.
Inter-Med filed from Racine, Wisconsin. Review took 197 calendar days (September 30, 2025 to April 15, 2026).
Clearance details
- Applicant
- Inter-Med, Inc.
- Product code
- Product code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
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