Cleared Traditional

K000577 - YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA (FDA 510(k) Clearance)

Class I Dental device.

K000577 · The Yoshida Dental Mfg. Co., Ltd. · Dental device
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.

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
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 158d · 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

All 7
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