Cleared Traditional

K801886 - BURR, DENTAL
(FDA 510(k) Clearance)

K801886 · Aesculap Instruments Corp. · Dental device

Aug 1980

Decision

23d

Days

Class 1

Risk

K801886 is an FDA 510(k) clearance for the BURR, DENTAL. This device is classified as a Bur, Dental (Class I - General Controls, product code EJL).

Submitted by Aesculap Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 23 days after receiving the submission on July 28, 1980.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number	K801886 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 1980
Decision Date	August 20, 1980
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—