X-MIND Trium
FDA 510(k) clearance K191719 · decided 2020-02-20
Clearance details
- K-number
- K191719
- Device name
- X-MIND Trium
- Applicant
- De Gotzen S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-26
- Decision date
- 2020-02-20
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Olgiate Olona, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.