Cleared Traditional

THERMAFIL ENDODONTIC OBTURATOR (K900986) - FDA 510(k) Clearance

Class I Dental device.

K900986 · Tulsa Dental Products, Ltd. · Dental device
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Nov 1990
Decision
257d
Days
Class 1
Risk

K900986 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 November 13, 1990 after a review of 257 days - an extended review 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: 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.

View all Tulsa Dental Products, Ltd. devices

Submission Details

510(k) Number K900986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1990
Decision Date November 13, 1990
Days to Decision 257 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 127d · This submission: 257d
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.