Cleared Traditional

K972642 - PERIO CONTROL II

K972642 is an FDA 510(k) clearance for PERIO CONTROL II, manufactured by Estrad B.V.. The device is a Class 1 Dental device with product code EIK cleared through the Traditional 510(k) pathway after a 195-day FDA review.

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

FDA 510(k) Submission Details - K972642

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 127d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

EIK Device Classification - Class 1, General Controls

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.