Submission Details
| 510(k) Number | K970975 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 17, 1997 |
| Decision Date | April 01, 1997 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
Cleared
Traditional
PROSTYLE INTRA
Apr 1997
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K970975 is an FDA 510(k) clearance for the PROSTYLE INTRA, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on April 1, 1997, 15 days after receiving the submission on March 17, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
Device Classification
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |
Manufacturer
Similar Devices — EHD Unit, X-ray, Extraoral With Timer
All 187
K252110 · Guangzhou Ajax Medical Equipment Co., Ltd.
· Mar 2026
K254018 · Guilin Refine Medical Instrument Co., Ltd.
· Feb 2026
K252909 · Ningbo Runyes Medical Instrument Co., Ltd.
· Feb 2026
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd.
· Sep 2025
K242185 · Raypia Co., Ltd.
· Dec 2024
K242591 · DRTECH Corporation
· Nov 2024
More from Planmeca Oy
View all
K230985
· OAS · Dec 2023
K200572
· LLZ · Dec 2020
K181576
· OAS · Sep 2018
K171385
· LLZ · Nov 2017
K160506
· OAS · May 2016