Cleared Traditional

K003650 - PERMLASTIC 3

K003650 is an FDA 510(k) clearance for PERMLASTIC 3, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K003650 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
80d
Days
Class 2
Risk

K003650 is an FDA 510(k) clearance for the PERMLASTIC 3. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on February 15, 2001 after a review of 80 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 - K003650

510(k) Number K003650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2000
Decision Date February 15, 2001
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
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 391
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K003650.
TAKE ONE BITE MODIFIED
K010994 · Kerr Corp. · Apr 2001
R-SI-LINE METAL-BITE
K010926 · R-Dental Dentalerzeugnisse GmbH · Apr 2001
TAKE 1
K003808 · Sybron Dental Specialties, Inc. · Mar 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001
ALGINATE IMPRESSION MATERIAL
K003426 · Rite-Dent Manufacturing Corp. · Jan 2001
PERMLASTIC 2
K001655 · Kerr Corp. · Aug 2000
K003650 · PERMLASTIC 3
Download PDF FDA Summary Sybron Dental Special…