Cleared Traditional

K910224 - THERMAPREP

K910224 is an FDA 510(k) clearance for THERMAPREP, manufactured by Tulsa Dental Products, Ltd.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K910224 · Tulsa Dental Products, Ltd. · Dental device
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Mar 1991
Decision
70d
Days
Class 1
Risk

K910224 is an FDA 510(k) clearance for the THERMAPREP. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - 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.

FDA 510(k) Submission Details - K910224

510(k) Number K910224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1991
Decision Date March 29, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 128d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
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 - EKM Gutta-percha

All 13
Devices cleared under the same product code (EKM) and FDA review panel - the closest regulatory comparables to K910224.
INJECT-R FILL
K931742 · Union Broach, Div. Moyco Industries, Inc. · May 1993
MICRODOSE RC-EZ
K924825 · Unicep · Mar 1993
TOUCH 'N HEAT MODEL 5002, MODIFICATION
K915243 · Analytic Technology · Jan 1992
THERMAFIL ENDODONTIC OBTURATOR
K900986 · Tulsa Dental Products, Ltd. · Nov 1990
ENDO-PREP
K896663 · Pulpdent Corp. · Feb 1990
HEATED GUTTA PERCHA DELIVERY SYSTEM
K832654 · Unitek Corp. · Sep 1983
K910224 · THERMAPREP
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