Cleared Traditional

K001655 - PERMLASTIC 2

K001655 is an FDA 510(k) clearance for PERMLASTIC 2, manufactured by Kerr Corp.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K001655 · Kerr Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
71d
Days
Class 2
Risk

K001655 is an FDA 510(k) clearance for the PERMLASTIC 2. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kerr Corp. (Orange, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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.

FDA 510(k) Submission Details - K001655

510(k) Number K001655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2000
Decision Date August 10, 2000
Days to Decision 71 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
57d faster than avg
Panel avg: 128d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 375
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K001655.
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
ALGINATE IMPRESSION MATERIAL
K003426 · Rite-Dent Manufacturing Corp. · Jan 2001
KWIKKMODEL
K001414 · R-Dental Dentalerzeugnisse GmbH · Aug 2000
TAKE 1 BITE
K001876 · Sybron Dental Specialties, Inc. · Jul 2000
CORRECT PLUS
K001218 · Jeneric/Pentron, Inc. · Jul 2000
K001655 · PERMLASTIC 2
Download PDF FDA Summary Kerr Corp.