FDA 510(k) K241071, NextDent Jet Denture Base; NextDent Jet Denture Teeth, by Vertex-Dental B.V.
FDA 510(k) K241071, NextDent Jet Denture Base; NextDent Jet Denture Teeth, by Vertex-Dental B.V.
| 510(k) Number | K241071 |
| Device Classification Name | Resin, Denture, Relining, Repairing, Rebasing |
| Device Name | NextDent Jet Denture Base; NextDent Jet Denture Teeth |
| Applicant | Vertex-Dental B.V. Centurionbaan 190 Soesterberg, NL 3769AV |
| Regulation Number | 872.376 |
| Classification Product Code | EBI |
| Date Received | 04/19/2024 |
| Decision Date | 09/04/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Dental |
| 510k Review Panel | Dental |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 1965 |
| Redacted Pages | 1607 |
| Unredacted Pages | 358 |
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