K254286
- 510(k) number
- K254286
- Device name
- Guided Bone Regeneration System
- Applicant
- DentalMaster(Xiamen)Medical Technology Co., Ltd. CN
- Product code
- DZL — Screw, Fixation, Intraosseous
- Decision date
- 2026-08-24
- Date received
- 2025-12-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K254286.pdf
Official FDA record: K254286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.