Cleared Traditional

K012427 - PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

K012427 is an FDA 510(k) clearance for PHARMAETHYL LOCAL PULP AND VITALITY TES..., manufactured by Specialites Septodont. The device is a Class 2 Dental device with product code EAT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K012427 · Specialites Septodont · Dental device
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Oct 2001
Decision
70d
Days
Class 2
Risk

K012427 is an FDA 510(k) clearance for the PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT. Classified as Tester, Pulp (product code EAT), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1720 - 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 Specialites Septodont devices

FDA 510(k) Submission Details - K012427

510(k) Number K012427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date October 09, 2001
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. No clinical trials required.

EAT Device Classification - Class 2, Special Controls

Product Code EAT Tester, Pulp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EAT Tester, Pulp

All 10
Devices cleared under the same product code (EAT) and FDA review panel - the closest regulatory comparables to K012427.
THERMIQUE
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K973439 · Sybron Dental Specialties, Inc. · Dec 1997
SYSTEM B HEAT SOURCE
K970715 · Sybron Dental Specialties, Inc. · Apr 1997
TOUCH N' HEAT
K963862 · Sybron Dental Specialties, Inc. · Dec 1996
ORTHO-ICE
K960799 · Ultimate Wireforms, Inc. · May 1996