Neodent Implant System
FDA 510(k) clearance K242686 · decided 2024-12-04
Clearance details
- K-number
- K242686
- Device name
- Neodent Implant System
- Applicant
- Jjgc Indústria E Comércia DE Materiais Dentários S.A.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-06
- Decision date
- 2024-12-04
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NHA
- Device class
- 2
- Regulation number
- 872.3630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Curitiba, BR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endoss recall (Z-1994-2026) | Straumann USA LLC | 2026-04-29 |