Cleared Traditional

K000577 - YOSHIDA WAVE PICT CAM INTRAORAL CAMERA

K000577 is the FDA 510(k) clearance for YOSHIDA WAVE PICT CAM INTRAORAL CAMERA by The Yoshida Dental Mfg. Co., Ltd.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K000577 · The Yoshida Dental Mfg. Co., Ltd. · Dental device
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May 2000
Decision
73d
Days
Class 1
Risk

K000577 is an FDA 510(k) clearance for the YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CA.... Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on May 5, 2000 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 The Yoshida Dental Mfg. Co., Ltd. devices

Submission Details

510(k) Number K000577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date May 05, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

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