Cleared Traditional

K962071 - SPIRIT S1/S2

K962071 is an FDA 510(k) clearance for SPIRIT S1/S2, manufactured by Pelton & Crane Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K962071 · Pelton & Crane Co. · Dental device
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Aug 1996
Decision
70d
Days
Class 1
Risk

K962071 is an FDA 510(k) clearance for the SPIRIT S1/S2. 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 August 6, 1996 after a review of 70 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

FDA 510(k) Submission Details - K962071

510(k) Number K962071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date August 06, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 186
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K962071.
CDR-CAM
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PORTA'PURE/DENTAL
K961409 · Water Solution Technologies · Jun 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556 · Scitech Solutions, Inc. · May 1996