Cleared Traditional

K-APATITE 20-40 MESH K-APATITE 40-60

K843557 · Katecho, Inc. · Dental

Nov 1984

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K843557 is an FDA 510(k) clearance for the K-APATITE 20-40 MESH K-APATITE 40-60, a Implant, Subperiosteal (Class II — Special Controls, product code ELE), submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 30, 1984, 81 days after receiving the submission on September 10, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.3645.

Submission Details

510(k) Number	K843557 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 1984
Decision Date	November 30, 1984
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—