Cleared Traditional

K862523 - MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
(FDA 510(k) Clearance)

K862523 · Walter Lorenz Surgical, Inc. · Dental device

Aug 1986

Decision

30d

Days

Class 1

Risk

K862523 is an FDA 510(k) clearance for the MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS. This device is classified as a Broach, Endodontic (Class I - General Controls, product code EKW).

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 1, 1986, 30 days after receiving the submission on July 2, 1986.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K862523 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 02, 1986
Decision Date	August 01, 1986
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—