Cleared Traditional

K840244 - BIOCERAM ZEST PLANT
(FDA 510(k) Clearance)

K840244 · Zest Anchors, Inc. · Dental

May 1984

Decision

102d

Days

Class 2

Risk

K840244 is an FDA 510(k) clearance for the BIOCERAM ZEST PLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Zest Anchors, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 102 days after receiving the submission on January 20, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K840244 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 1984
Decision Date	May 01, 1984
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—