Star E900 Electric System
FDA 510(k) clearance K251701 · decided 2026-01-12
Clearance details
- K-number
- K251701
- Device name
- Star E900 Electric System
- Applicant
- Dentalez, Inc., Stardental Division
- Decision
- Substantially Equivalent
- Date received
- 2025-06-02
- Decision date
- 2026-01-12
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- EBW
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lancaster, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.