Cleared Traditional

TMJ CANNULA SET

K871648 · Aspen Laboratories, Inc. · Dental
Jun 1987
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K871648 is an FDA 510(k) clearance for the TMJ CANNULA SET, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on June 8, 1987, 41 days after receiving the submission on April 28, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K871648 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1987
Decision Date June 08, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120