FDA 510(k) clearance · back to tracker
Guided Bone Regeneration System
DentalMaster(Xiamen)Medical Technology Co., Ltd. cleared K254286 on 2026-08-24, decision: substantially equivalent
K-number
K254286
Sponsor
DentalMaster(Xiamen)Medical Technology Co., Ltd.
Device
Guided Bone Regeneration System
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-08-24
Product code
DZL
Advisory committee
Dental
Medical specialty
Dental
Regulation number
872.4880
Official FDA record
Open K254286on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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