Cleared Traditional

K872943 - DISPOSABLE ARTICULATOR (FDA 510(k) Clearance)

Aug 1987
Decision
14d
Days
Class 1
Risk

K872943 is an FDA 510(k) clearance for the DISPOSABLE ARTICULATOR. This device is classified as a Articulators (Class I - General Controls, product code EJP).

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on August 11, 1987, 14 days after receiving the submission on July 28, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3150.

Submission Details

510(k) Number K872943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1987
Decision Date August 11, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EJP — Articulators
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.3150