Cleared Traditional

K834363 - ENDIX RADICULAR BIOCERAMIC PIN

K834363 is an FDA 510(k) clearance for ENDIX RADICULAR BIOCERAMIC PIN, manufactured by C.B.S. Biotechnics, Inc.. The device is a Class 2 Dental device with product code ELS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K834363 · C.B.S. Biotechnics, Inc. · Dental device
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Feb 1984
Decision
123d
Days
Class 2
Risk

K834363 is an FDA 510(k) clearance for the ENDIX RADICULAR BIOCERAMIC PIN. Classified as Splint, Endodontic Stabilizing (product code ELS), Class II - Special Controls.

Submitted by C.B.S. Biotechnics, Inc. (Walker, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3890 - 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 C.B.S. Biotechnics, Inc. devices

FDA 510(k) Submission Details - K834363

510(k) Number K834363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1983
Decision Date February 27, 1984
Days to Decision 123 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 128d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELS Device Classification - Class 2, Special Controls

Product Code ELS Splint, Endodontic Stabilizing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3890
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.