Cleared Traditional

K900986 - THERMAFIL ENDODONTIC OBTURATOR

K900986 is an FDA 510(k) clearance for THERMAFIL ENDODONTIC OBTURATOR, 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 257-day FDA review.

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

FDA 510(k) Submission Details - K900986

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.

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.