Cleared Traditional

K875221 - TOOTH PRESERVING SYSTEM (FDA 510(k) Clearance)

Class I Pathology device.

K875221 · Biological Rescue Products, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Biological Rescue Products, Inc. devices

Submission Details

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
37d slower than avg
Panel avg: 77d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.