Cleared Traditional

Q-LITE 75 LIGHT CURE UNIT

K991865 · Rolence Enterprise Co. , Ltd. · Dental
Jul 1999
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K991865 is an FDA 510(k) clearance for the Q-LITE 75 LIGHT CURE UNIT, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Rolence Enterprise Co. , Ltd. (Chungli 320, TW). The FDA issued a Cleared decision on July 20, 1999, 49 days after receiving the submission on June 1, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K991865 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1999
Decision Date July 20, 1999
Days to Decision 49 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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