Cleared Traditional

K980726 - ULTRA-BLASTER (FDA 510(k) Clearance)

K980726 · Ultradent Products, Inc. · Dental device

May 1998

Decision

77d

Days

Class 2

Risk

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

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on May 12, 1998, 77 days after receiving the submission on February 24, 1998.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6080.

Submission Details

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

Device Classification

Product Code	KOJ — Airbrush
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 872.6080