Cleared Traditional

K955573 - OPTIBLAST INTRAORAL SANDBLASTER

K955573 is an FDA 510(k) clearance for OPTIBLAST INTRAORAL SANDBLASTER, manufactured by Buffalo Dental Mfg. Co., Inc.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K955573 · Buffalo Dental Mfg. Co., Inc. · Dental device
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May 1996
Decision
148d
Days
Class 2
Risk

K955573 is an FDA 510(k) clearance for the OPTIBLAST INTRAORAL SANDBLASTER. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Syosset, US). The FDA issued a Cleared decision on May 3, 1996 after a review of 148 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 Buffalo Dental Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K955573

510(k) Number K955573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1995
Decision Date May 03, 1996
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 29
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K955573.
SIMPLEX AIRBRATOR
K970249 · Simplex Medical Systems, Inc. · May 1997
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
K964145 · Crystal Mark, Inc. · Dec 1996
MICADENT
K964059 · Hampton Research · Dec 1996
JETSTREAM CAVITY PREPARATION SYSTEM
K955050 · Dove Systems, Inc. · Mar 1996
MICROPREP CAVITY PREPERATION SYSTEM
K932997 · Sunrise Technologies, Inc. · Apr 1994
FIBER HEMOFILTERS FH55-FH77 & 88
K840720 · Gambro, Inc. · Apr 1984