Cleared Traditional

AIRDENT RADIANCE CURING LIGHT

K982615 · Air Techniques, Inc. · Dental
Aug 1998
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K982615 is an FDA 510(k) clearance for the AIRDENT RADIANCE CURING LIGHT, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on August 24, 1998, 28 days after receiving the submission on July 27, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K982615 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1998
Decision Date August 24, 1998
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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