Cleared Traditional

THERMAFIL ENDODONTIC OBTURATOR (K881139) - FDA 510(k) Clearance

Class I Dental device.

K881139 · Tulsa Dental Products, Ltd. · Dental device
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Apr 1988
Decision
21d
Days
Class 1
Risk

K881139 is an FDA 510(k) clearance for the THERMAFIL ENDODONTIC OBTURATOR. 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 April 7, 1988 after a review of 21 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.

View all Tulsa Dental Products, Ltd. devices

Submission Details

510(k) Number K881139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1988
Decision Date April 07, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.