NextDent Denture 3D+
FDA 510(k) clearance K191497 · decided 2019-11-01
Clearance details
- K-number
- K191497
- Device name
- NextDent Denture 3D+
- Applicant
- Vertex-Dental B.V.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-05
- Decision date
- 2019-11-01
- Days to decision
- 149 days
- Clearance type
- Abbreviated
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Soesterberg, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.