K252090
- 510(k) number
- K252090
- Device name
- Pterygoid Indication for GM Helix Implants
- Applicant
- JJGC Indústria e Comércio de Materiais Dentários S.A. BR
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-12-12
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252090.pdf
Official FDA record: K252090
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.