Neodent InLab Validated Workflow
FDA 510(k) clearance K252727 · decided 2026-01-07
Clearance details
- K-number
- K252727
- Device name
- Neodent InLab Validated Workflow
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-28
- Decision date
- 2026-01-07
- Days to decision
- 132 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
No recalls on record reference this clearance.