Cleared Traditional

ABIODENT PERIOTEMP(R) SYSTEM

K911643 · Abiomed, Inc. · Dental
Jul 1991
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K911643 is an FDA 510(k) clearance for the ABIODENT PERIOTEMP(R) SYSTEM, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on July 9, 1991, 88 days after receiving the submission on April 12, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K911643 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1991
Decision Date July 09, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIL — Gauge, Depth, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565