Cleared Traditional

K942562 - PROSTHOFLEX

K942562 is an FDA 510(k) clearance for PROSTHOFLEX, manufactured by Knopf Assoc, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K942562 · Knopf Assoc, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
203d
Days
Class 2
Risk

K942562 is an FDA 510(k) clearance for the PROSTHOFLEX. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Knopf Assoc, Inc. (Livingston, US). The FDA issued a Cleared decision on December 20, 1994 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Knopf Assoc, Inc. devices

FDA 510(k) Submission Details - K942562

510(k) Number K942562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date December 20, 1994
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 261
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K942562.
PRECISE DENTURE BASE RESIN
K952351 · Dentsply Intl. · Jul 1995
SEALDENT
K944466 · Scientific Pharmaceuticals, Inc. · Mar 1995
HARRY J. BOSWORTH RESIN I.
K946317 · Harry J. Bosworth Co. · Feb 1995
COE-SOFT LC
K940565 · GC America, Inc. · May 1994
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994