Cleared Traditional

K992649 - ATD AUTOMATIC BRIDGE REMOVER (FDA 510(k) Clearance)

Class I Dental device.

K992649 · J. Morita USA, Inc. · Dental device
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Oct 1999
Decision
84d
Days
Class 1
Risk

K992649 is an FDA 510(k) clearance for the ATD AUTOMATIC BRIDGE REMOVER. Classified as Remover, Crown (product code EIS), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 29, 1999 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 J. Morita USA, Inc. devices

Submission Details

510(k) Number K992649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1999
Decision Date October 29, 1999
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIS Remover, Crown
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.