FDA.report

510(k) K253337

Device
REGEN Bioactive Cement
Applicant
Inter-Med, Inc.
510(k) number
K253337
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-15
Date received
2025-09-30
Regulation
872.3275
Classification name
Cement, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Alex Johnson
Address
2200 S. St. Racine WI US 53404 53404

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EMA

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K240714Insure® Universal; Insure® Universal AutomixCosmedent, Inc.2024-07-24
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K240888Calibra Abutment Resin CementDentsply Sirona2024-04-02
K233161BeautiLink SAShofu Dental Corporation2023-09-28