Cleared Traditional

K955050 - JETSTREAM CAVITY PREPARATION SYSTEM

K955050 is an FDA 510(k) clearance for JETSTREAM CAVITY PREPARATION SYSTEM, manufactured by Dove Systems, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K955050 · Dove Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
125d
Days
Class 2
Risk

K955050 is an FDA 510(k) clearance for the JETSTREAM CAVITY PREPARATION SYSTEM. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Dove Systems, Inc. (Concord, US). The FDA issued a Cleared decision on March 7, 1996 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - 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 Dove Systems, Inc. devices

FDA 510(k) Submission Details - K955050

510(k) Number K955050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1995
Decision Date March 07, 1996
Days to Decision 125 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
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.

Regulatory Peers - KOJ Airbrush

All 28
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K955050.
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
K964145 · Crystal Mark, Inc. · Dec 1996
MICADENT
K964059 · Hampton Research · Dec 1996
OPTIBLAST INTRAORAL SANDBLASTER
K955573 · Buffalo Dental Mfg. Co., Inc. · May 1996
MICROPREP CAVITY PREPERATION SYSTEM
K932997 · Sunrise Technologies, Inc. · Apr 1994
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · Gambro, Inc. · Apr 1984