Cleared Traditional

K994174 - FRIALIT-2 MH-2 ABUTMENT
(FDA 510(k) Clearance)

K994174 · Friadent GmbH · Dental

Apr 2000

Decision

132d

Days

Class 2

Risk

K994174 is an FDA 510(k) clearance for the FRIALIT-2 MH-2 ABUTMENT. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).

Submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on April 20, 2000, 132 days after receiving the submission on December 10, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K994174 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 1999
Decision Date	April 20, 2000
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF