Stela Automix System— 510(k) K222581

Substantially Equivalent

Sdi Limited

FDA 510(k) clearance K222581 for Stela Automix System, Substantially Equivalent on 2022-10-28. Applicant: Sdi Limited. Device class: 2.

Clearance details

Applicant: Sdi Limited
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2022-08-26
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Sdi Limited

K222583 — Stela Capsule System2022-10-28
K214118 — Riva Cem Automix2022-08-30
K191656 — Zipbond2019-12-02
K172047 — Riva Star2018-04-11
K102984 — AURA2010-12-08

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