Cleared Traditional

K080025 - LED.L, LED.M, LED.G, LED.B

K080025 is an FDA 510(k) clearance for LED.L, manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K080025 · Guilin Woodpecker Medical Instrument Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
75d
Days
Class 2
Risk

K080025 is an FDA 510(k) clearance for the LED.L, LED.M, LED.G, LED.B. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on March 19, 2008 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guilin Woodpecker Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K080025

510(k) Number K080025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 128d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 178
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