Augmented Gingival Matrix— 510(k) K250512

Substantially Equivalent

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.

FDA 510(k) clearance K250512 for Augmented Gingival Matrix, Substantially Equivalent on 2025-12-05. Applicant: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd..

Clearance details

Applicant: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Product code: Code NPL
Advisory panel: Dental
Date received: 2025-02-21
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.