Cleared Traditional

K143696 - Spirit

K143696 is an FDA 510(k) clearance for Spirit, manufactured by Pelton & Crane. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K143696 · Pelton & Crane · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
268d
Days
Class 1
Risk

K143696 is an FDA 510(k) clearance for the Spirit. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Pelton & Crane (Charlotte, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K143696

510(k) Number K143696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date September 18, 2015
Days to Decision 268 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 128d · This submission: 268d
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 256
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K143696.
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TENEO Dental Treatment Unit and Accessories
K151045 · Sirona Dental Systems GmbH · Jul 2015
INTEGO Family and Accesories
K150909 · Sirona Dental Systems GmbH · Jul 2015
UnicLine Mobile
K150490 · Heka Dental A/S · Apr 2015
K143696 · Spirit
Download PDF FDA Summary Pelton & Crane