PROSTYLE INTRA— 510(k) K970975

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K970975 for PROSTYLE INTRA, Substantially Equivalent on 1997-04-01. Applicant: Planmeca Oy. Device class: 2.

Clearance details

Applicant: Planmeca Oy
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 1997-03-17
Decision date: 1997-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHD

K260367 — Portable Dental X-ray System Model PDX nova2026-05-27
K253864 — NOMAD Pro 32026-03-20
K252110 — Dental X-RAY Unit (AJX200)2026-03-12
K254018 — Portable Dental X-ray Device (GT-1)2026-02-19
K252909 — Diagnostic X-Ray Equipment Model POCT222026-02-03

More clearances from Planmeca Oy

K230985 — Planmeca Viso2023-12-28
K200572 — Planmeca Romexis2020-12-02
K181576 — Planmeca Viso2018-09-13
K171385 — Planmeca Romexis2017-11-14
K160506 — Planmeca ProMax 3D Max, Planmeca Maximity2016-05-20

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