Cleared Traditional

K854702 - PLASTIC MOUNTING RINGS (FDA 510(k) Clearance)

Mar 1986
Decision
105d
Days
Class 1
Risk

K854702 is an FDA 510(k) clearance for the PLASTIC MOUNTING RINGS. This device is classified as a Articulators (Class I - General Controls, product code EJP).

Submitted by Almore Intl., Inc. (Portland, US). The FDA issued a Cleared decision on March 6, 1986, 105 days after receiving the submission on November 21, 1985.

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

Submission Details

510(k) Number K854702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date March 06, 1986
Days to Decision 105 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