Cleared Traditional

CYBERJET LOCAL ANESTHESIA SYSTEM

K964802 · Intra Vantage, Inc. · Dental

May 1997

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K964802 is an FDA 510(k) clearance for the CYBERJET LOCAL ANESTHESIA SYSTEM, a Injector, Jet, Mechanical-powered (Class II — Special Controls, product code EGM), submitted by Intra Vantage, Inc. (Concord, US). The FDA issued a Cleared decision on May 27, 1997, 179 days after receiving the submission on November 29, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number	K964802 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 1996
Decision Date	May 27, 1997
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF