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K Number
K955573
Device Name
OPTIBLAST INTRAORAL SANDBLASTER
Manufacturer
BUFFALO DENTAL MFG. CO., INC.
Date Cleared
1996-05-03

(148 days)

Product Code
KOJ
Regulation Number
872.6080
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, there is no information available regarding the acceptance criteria, study details, or performance of the "Optiblast Intraoral Sandblaster." The document is a 510(k) premarket notification letter from the FDA, confirming substantial equivalence to a predicate device and outlining regulatory requirements. It does not contain clinical study data, acceptance criteria, or performance metrics for the device itself.

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”