Orthopantomograph OP 3D— 510(k) K180947

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K180947 for Orthopantomograph OP 3D, Substantially Equivalent on 2018-06-07. Applicant: Palodex Group OY. Device class: 2.

Clearance details

Applicant: Palodex Group OY
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2018-04-11
Decision date: 2018-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code OAS

K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series)2026-07-23
K250839 — Dental X-ray System2026-06-11
K260662 — Dental Cone Beam Computed Tomography System2026-06-04
K253935 — medXion NEXUS2026-05-15
K260462 — RCT8002026-04-09

More clearances from Palodex Group OY

K241249 — Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)2024-09-12
K230505 — Orthopantomograph OP 3D LX2023-06-09
K173646 — FS Ergo2017-12-19
K163423 — Orthopantomograph OP3002017-08-31
K162799 — Cliniview2017-04-25

Recalls naming K180947

K-number listed on FDA's recall record

Z-1101-2019 — cone-beam CT systemClass II·Ongoing·KaVo Dental Technologies LLC·20181231

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180947.

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