Stratasys TrueDent
FDA 510(k) clearance K220771 · decided 2022-07-07
Clearance details
- K-number
- K220771
- Device name
- Stratasys TrueDent
- Applicant
- Stratasys, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-16
- Decision date
- 2022-07-07
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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