Cleared Traditional

PERIO-TEST (K872215) - FDA 510(k) Clearance

Class I Dental device.

K872215 · Dr. Bernard Loewenthal · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
31d
Days
Class 1
Risk

K872215 is an FDA 510(k) clearance for the PERIO-TEST. Classified as Gauge, Depth, Instrument, Dental (product code EIL), Class I - General Controls.

Submitted by Dr. Bernard Loewenthal (Portsmouth, US). The FDA issued a Cleared decision on July 10, 1987 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dr. Bernard Loewenthal devices

Submission Details

510(k) Number K872215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date July 10, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIL Gauge, Depth, Instrument, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.