Cleared Traditional

SURGICAL VITEX

K862926 · Jeneric Ind. · Dental
Aug 1986
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K862926 is an FDA 510(k) clearance for the SURGICAL VITEX, a Implant, Subperiosteal (Class II — Special Controls, product code ELE), submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on August 29, 1986, 28 days after receiving the submission on August 1, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3645.

Submission Details

510(k) Number K862926 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1986
Decision Date August 29, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELE — Implant, Subperiosteal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3645