Cleared Traditional

OPTIBLAST INTRAORAL SANDBLASTER (K955573) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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.