Cleared Traditional

K946187 - SPIRIT II AND SPIRIT TREATMENT CENTER (FDA 510(k) Clearance)

Class I Dental device.

K946187 · Pelton & Crane Co. · Dental device
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Mar 1995
Decision
71d
Days
Class 1
Risk

K946187 is an FDA 510(k) clearance for the SPIRIT II AND SPIRIT TREATMENT CENTER. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pelton & Crane Co. (Charlotte, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 71 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 Pelton & Crane Co. devices

Submission Details

510(k) Number K946187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date March 01, 1995
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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.

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