OSSIX Plus— 510(k) K262415

Substantially Equivalent

Datum Dental, Ltd.

FDA 510(k) clearance K262415 for OSSIX Plus, Substantially Equivalent on 2026-10-29. Applicant: Datum Dental, Ltd.. Device class: 2.

Clearance details

Applicant: Datum Dental, Ltd.
Product code: Product code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2026-07-15
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yavne Centra, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPL

K242817 — Jason membrane2025-12-12
K250512 — Augmented Gingival Matrix2025-12-05
K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®2025-11-25
K251062 — Geistlich Bio-Gide +6 more2025-08-14
K250833 — SwissMembrane X; SwissMembrane X Socket2025-04-15

More clearances from Datum Dental, Ltd.

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