Guided Bone Regeneration System— 510(k) K254286
Substantially EquivalentDentalMaster(Xiamen)Medical Technology Co., Ltd.
FDA 510(k) clearance K254286 for Guided Bone Regeneration System, Substantially Equivalent on 2026-08-24. Applicant: DentalMaster(Xiamen)Medical Technology Co., Ltd.. Device class: 2.
Summary
DentalMaster (Xiamen) Medical Technology filed a Guided Bone Regeneration System under product code DZL, intraosseous fixation screws. The device name is generic, and the record lists no components or model numbers.
Class II, 21 CFR 872.4880. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).
DentalMaster filed from Xiamen, China. The decision came 236 calendar days after receipt (December 31, 2025 to August 24, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- DentalMaster(Xiamen)Medical Technology Co., Ltd.
- Product code
- Product code DZL
- Device class
- Class 2
- Regulation
- 21 CFR 872.4880
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiamen, CN
Recent devices under product code DZL
view allAdverse events under product code DZL
product code DZL- Injury
- 168
- Total
- 168
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.