510(k) clearance
Guided Bone Regeneration System
- 510(k) number
- K254286
- Applicant
- DentalMaster(Xiamen)Medical Technology Co., Ltd.
- Decision date
- Aug 24, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DZL
- Device type
- Screw, Fixation, Intraosseous
- Device class
- Class II
- Regulation
- 21 CFR 872.4880
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Xiamen, CN