Clearance Summary
Pterygoid Indication for GM Helix Implants received FDA 510(k) clearance under submission number K252090, sponsored by JJGC Indústria e Comércio de Materiais Dentários S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-12-12.
- Submission: K252090
- Applicant / Sponsor: JJGC Indústria e Comércio de Materiais Dentários S.A.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2025-12-12
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.