BIO-SCREEN— 510(k) K082668
Substantially EquivalentAddent, Inc.
FDA 510(k) clearance K082668 for BIO-SCREEN, Substantially Equivalent on 2009-01-23. Applicant: Addent, Inc.. Device class: 2.
Clearance details
- Applicant
- Addent, Inc.
- Product code
- Code NXV
- Device class
- Class 2
- Regulation
- 21 CFR 872.6350
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danbury, CT, US
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