Cleared Traditional

FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA

K994376 · Friadent GmbH · Dental

Mar 2000

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K994376 is an FDA 510(k) clearance for the FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA, 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 March 24, 2000, 88 days after receiving the submission on December 27, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K994376 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1999
Decision Date	March 24, 2000
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF