PM 2002 CC PROLINE— 510(k) K970263

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K970263 for PM 2002 CC PROLINE, Substantially Equivalent on 1997-02-26. 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: 1997-01-23
Decision date: 1997-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHD

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K254018 — Portable Dental X-ray Device (GT-1)2026-02-19
K252909 — Diagnostic X-Ray Equipment Model POCT222026-02-03

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K160506 — Planmeca ProMax 3D Max, Planmeca Maximity2016-05-20

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