Cleared Traditional

K926190 - ALRAND INC. (DENTAL HAND INSTRUMENTS) (FDA 510(k) Clearance)

Jan 1994
Decision
405d
Days
Class 1
Risk

K926190 is an FDA 510(k) clearance for the ALRAND INC. (DENTAL HAND INSTRUMENTS). This device is classified as a Articulators (Class I - General Controls, product code EJP).

Submitted by Alrand, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 18, 1994, 405 days after receiving the submission on December 9, 1992.

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

Submission Details

510(k) Number K926190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date January 18, 1994
Days to Decision 405 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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