Cleared Traditional

MANI DIA-BURS

K913651 · The Lahr Consulting Group, Inc. · Dental

Jan 1992

Decision

151d

Days

Class 1

Risk

About This 510(k) Submission

K913651 is an FDA 510(k) clearance for the MANI DIA-BURS, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by The Lahr Consulting Group, Inc. (Mahwah, US). The FDA issued a Cleared decision on January 14, 1992, 151 days after receiving the submission on August 16, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number	K913651 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 1991
Decision Date	January 14, 1992
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement