FDA.report

510(k) K250156

Device
Choice 2 DC
Applicant
Bisco, Inc.
510(k) number
K250156
Product code
EMA
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-11
Date received
2025-01-21
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
Jessica Bernstein
Address
1100 W. Irving Park Rd. Schaumburg IL US 60193 60193

FDA Registration Numbers

Source Documents

510(k) summary PDF

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