Cleared Traditional

K980726 - ULTRA-BLASTER

K980726 is an FDA 510(k) clearance for ULTRA-BLASTER, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K980726 · Ultradent Products, Inc. · Dental device
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May 1998
Decision
77d
Days
Class 2
Risk

K980726 is an FDA 510(k) clearance for the ULTRA-BLASTER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K980726

510(k) Number K980726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date May 12, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K980726.
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
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K980216 · Kreativ, Inc. · Jun 1998
AIRPREP SYSTEM - MODEL 9001
K974488 · Asi Medical, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998
MICROETCHER AP
K970589 · Danville Engineering, Inc. · Sep 1997
MICROJET CAVITY PREPARATION SYSTEM
K964755 · Midwest Dental Products Corp. · Sep 1997