Cleared Traditional

K874118 - MODEL 410 DENTAL X-RAY FILM PROCESSORS
(FDA 510(k) Clearance)

Nov 1987
Decision
28d
Days
Class 2
Risk

K874118 is an FDA 510(k) clearance for the MODEL 410 DENTAL X-RAY FILM PROCESSORS. This device is classified as a Processor, Radiographic-film, Automatic, Dental (Class II - Special Controls, product code EGY).

Submitted by Dent-X Co. (Elmsford, US). The FDA issued a Cleared decision on November 6, 1987, 28 days after receiving the submission on October 9, 1987.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number K874118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1987
Decision Date November 06, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code EGY — Processor, Radiographic-film, Automatic, Dental
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1900

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