Cleared Traditional

PERIO CONTROL II (K972642) - FDA 510(k) Clearance

Class I Dental device.

K972642 · Estrad B.V. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
195d
Days
Class 1
Risk

K972642 is an FDA 510(k) clearance for the PERIO CONTROL II. Classified as Carver, Wax, Dental (product code EIK), Class I - General Controls.

Submitted by Estrad B.V. (Deer Field, US). The FDA issued a Cleared decision on January 26, 1998 after a review of 195 days - an extended review 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: 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 Estrad B.V. devices

Submission Details

510(k) Number K972642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date January 26, 1998
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 127d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIK Carver, Wax, 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.