Cleared Traditional

DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP

K915207 · Bay Technical Products, Inc. · Dental
Feb 1992
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K915207 is an FDA 510(k) clearance for the DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP, a Clamp, Rubber Dam (Class I — General Controls, product code EEF), submitted by Bay Technical Products, Inc. (Fremont, US). The FDA issued a Cleared decision on February 14, 1992, 88 days after receiving the submission on November 18, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K915207 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1991
Decision Date February 14, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EEF — Clamp, Rubber Dam
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300