DS Core Detect— 510(k) K253009
Substantially EquivalentDentsply Sirona, Inc.
FDA 510(k) clearance K253009 for DS Core Detect, Substantially Equivalent on 2026-01-07. Applicant: Dentsply Sirona, Inc.. Device class: 2.
Clearance details
- Applicant
- Dentsply Sirona, Inc.
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
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