Cleared Traditional

K981666 - 2.5 MM LACTOSORB SCREWS (FDA 510(k) Clearance)

K981666 · Biomet, Inc. · Dental device

Nov 1998

Decision

176d

Days

Class 2

Risk

K981666 is an FDA 510(k) clearance for the 2.5 MM LACTOSORB SCREWS. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 3, 1998, 176 days after receiving the submission on May 11, 1998.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number	K981666 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 11, 1998
Decision Date	November 03, 1998
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF