Cleared Traditional

CB BUR

K863097 · Beavers Dental, Div. Sybron Canada, Ltd. · Dental
Aug 1986
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K863097 is an FDA 510(k) clearance for the CB BUR, a Bur, Dental (Class I — General Controls, product code EJL), submitted by Beavers Dental, Div. Sybron Canada, Ltd. (Washington, US). The FDA issued a Cleared decision on August 26, 1986, 12 days after receiving the submission on August 14, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number K863097 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1986
Decision Date August 26, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJL — Bur, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3240