Cleared Traditional

CYBERJET LOCAL ANESTHESIA SYSTEM (K964802) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964802 · Intra Vantage, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
179d
Days
Class 2
Risk

K964802 is an FDA 510(k) clearance for the CYBERJET LOCAL ANESTHESIA SYSTEM. Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by Intra Vantage, Inc. (Concord, US). The FDA issued a Cleared decision on May 27, 1997 after a review of 179 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Intra Vantage, Inc. devices

Submission Details

510(k) Number K964802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 127d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.