Cleared Traditional

CREMEEN ALVEOLAR BONE CALIPER

K872098 · Bowen & Company, Inc. · Dental
Jul 1987
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K872098 is an FDA 510(k) clearance for the CREMEEN ALVEOLAR BONE CALIPER, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on July 31, 1987, 60 days after receiving the submission on June 1, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K872098 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1987
Decision Date July 31, 1987
Days to Decision 60 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