Cleared Traditional

LED.L, LED.M, LED.G, LED.B

K080025 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental
Mar 2008
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K080025 is an FDA 510(k) clearance for the LED.L, LED.M, LED.G, LED.B, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on March 19, 2008, 75 days after receiving the submission on January 4, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K080025 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2008
Decision Date March 19, 2008
Days to Decision 75 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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