Cleared Traditional

K875221 - TOOTH PRESERVING SYSTEM

K875221 is an FDA 510(k) clearance for TOOTH PRESERVING SYSTEM, manufactured by Biological Rescue Products, Inc.. The device is a Class 1 Pathology device with product code KJF cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K875221 · Biological Rescue Products, Inc. · Pathology device
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Apr 1988
Decision
114d
Days
Class 1
Risk

K875221 is an FDA 510(k) clearance for the TOOTH PRESERVING SYSTEM. Classified as System, Suspension, Cell Culture (product code KJF), Class I - General Controls.

Submitted by Biological Rescue Products, Inc. (Pottstown, US). The FDA issued a Cleared decision on April 14, 1988 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - the FDA pathology device 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K875221

510(k) Number K875221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date April 14, 1988
Days to Decision 114 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 78d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

KJF Device Classification - Class 1, General Controls

Product Code KJF System, Suspension, Cell Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
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.